Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links

Enforcement Report - Week of July 11, 2012

-

Your browser settings indicate that JavaScript is currently disabled. Some features on this page may require the use of JavaScript. You may need to enable JavaScript in order to enjoy the full functionality of this page.

PRODUCT VIEW EVENT VIEW PRINT-FRIENDLY VIEW PENDING MORE INFO DOWNLOAD CSV

Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Devices Event

Event ID	61943
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Carefusion 2200 Inc
City	McGaw Park
State	IL
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.

Associated Products

Product Description	AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Code Info	product codes 10127-4H1, 10331N-4S2, 10351-4H2, 10387-4S2, 10555-4S2, 10706-4S2, 10790-4S2, 10814-4S2, 10849-4S2, 1175-4H2, 1208-4H1, 1553-4H1, 1815-409, 1998-4H1, 2119-4S2G, 2120-4S2G, 4319-4H2, 4326-4H2, 4652-5014677-4H2, 4875-4H2, 5665-4H2, 5682-409, 5732-4H1, 5868-4H2, 6002-4H2, 6040-501, 6074-4H1, 6198-4H2, 6274-H12, 6301-H12, 6313-501, 6459-4H2; 6485-4H2, 6588-4H2, 6942-4H2, 7100-4S2, 7147-4S2, 7156-4S2, 7184-4S2, 7206-4S2, 7213-4S2, 7354-4S2, 7395-4S2, 7407-4S2, 7441-4S2, 7483-4S2, 7526-4S2, 7575-4S2, 7582-4S2, 7588-4S2, 9053-4S2, 9054-4S2, 9055-4S2, 9056-4S2, 9058-4S2, RC41-12027, RC41-18039, RC41-18052, RC41-18060, RC51-12074, RC51-18004, RT4851-00, RT4851-12 and RT4851-18; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
Classification	Class I
Reason for Recall	The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Product Quantity
Recall Number	Z-1899-2012

Product Description	AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Code Info	product codes 0260-503; 0778-503, 10392-503, 10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1535-503, 1853-503, 5599-503, 5643-503, 5898-503, 6189-503, 6800-503 and RC41-00097; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
Classification	Class I
Reason for Recall	The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Product Quantity
Recall Number	Z-1900-2012

Product Description	AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Code Info	product codes 5925-504 and 6603-504; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
Classification	Class I
Reason for Recall	The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Product Quantity
Recall Number	Z-1901-2012

Class I Food/Cosmetics Event

Event ID	62340
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Jun-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Hannaford Bros.
City	Scarborough
State	ME
Country	US
Distribution Pattern	NH, MA, ME, NY and VT

Associated Products

Product Description	Hannaford brand Mini Frosted Cookies, 10 oz UPC # 4126872374
Code Info	Product sold in retail bakery prior to 6/15/12
Classification	Class I
Reason for Recall	Undeclared egg
Product Quantity	990 units
Recall Number	F-1687-2012

Class I Food/Cosmetics Event

Event ID	62369
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Deep Foods Inc
City	Union
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Crispy by TWI Foods Almond Cake Rusk, Biscuit, Net Wt 26.4 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court , Mississauga, Ont, Canada . L5S 1S3
Code Info	UPC 627265002176 with best by dates up to March 27, 2013
Classification	Class I
Reason for Recall	Products may contain undeclared milk.
Product Quantity
Recall Number	F-1720-2012

Product Description	Crispy by TWI Foods Coconut Cookies, Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 2600 Drew Road, Mississauga, Ont, Canada L4T 3M5.
Code Info	UPC 627265005214 with best by dates up to March 27, 2013
Classification	Class I
Reason for Recall	Products may contain undeclared milk.
Product Quantity
Recall Number	F-1721-2012

Product Description	Crispy by TWI Foods Almond Cookies, Biscuit, Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3
Code Info	UPC 6 27265 005221 6; All codes, best before March 29, 2013.
Classification	Class I
Reason for Recall	Products may contain undeclared milk.
Product Quantity	not provided.
Recall Number	F-1722-2012

Product Description	Crispy by TWI Foods Pistachio Cookies, Biscuit, Net Wt 7 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3.
Code Info	UPC 6 27265 00161 2; All codes, best before March 29, 2013.
Classification	Class I
Reason for Recall	Products may contain undeclared milkand almonds.
Product Quantity	not provided.
Recall Number	F-1723-2012

Class II Biologics Event

Event ID	39122
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Mar-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Center of Greater Kansas City
City	Kansas City
State	MO
Country	US
Distribution Pattern	KS

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W045007902862
Classification	Class II
Reason for Recall	Blood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-1754-12

Class II Biologics Event

Event ID	40631
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Aug-05
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Belle Bonfils Memorial Blood Center
City	Denver
State	CO
Country	US
Distribution Pattern	Switzerland, CO

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	9049505
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of living in an HIV-O risk area, were distributed.
Product Quantity	1 unit
Recall Number	B-1742-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	9049505
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of living in an HIV-O risk area, were distributed.
Product Quantity	1 unit
Recall Number	B-1743-12

Class II Biologics Event

Event ID	46033
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Sep-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	American National Red Cross (The)
City	Omaha
State	NE
Country	US
Distribution Pattern	Omaha, NE

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	09GZ09998; 09GZ10010; 09GZ10011
Classification	Class II
Reason for Recall	Blood products, which were labeled as leukoreduced, but did not have leukoreduction testing completed were distributed.
Product Quantity	3 units
Recall Number	B-1755-12

Class II Biologics Event

Event ID	47955
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Mar-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	ARC Blood Services, New England Region
City	Dedham
State	MA
Country	US
Distribution Pattern	MA, NY

Associated Products

Product Description	Red Blood Cells
Code Info	004LE80082, 004LE80083, 004LE80084, 004LE80086, 004LE80087, 004LE80095, 004LE80097, 004LE80098, 004LE80099, 004LE80100
Classification	Class II
Reason for Recall	Blood products, collected using equipment that was not validated, were distributed.
Product Quantity	10 units
Recall Number	B-2028-12

Product Description	Fresh Frozen Plasma
Code Info	004LE80082, 004LE80083, 004LE80087, 004LE80099
Classification	Class II
Reason for Recall	Blood products, collected using equipment that was not validated, were distributed.
Product Quantity	4 units
Recall Number	B-2029-12

Class II Biologics Event

Event ID	56083
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-May-10
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services L.P.
City	Dubuque
State	IA
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	09DIAJ5514;09DIAK4140;09DIAK3063;09DIAJ8774;09DIAJ7748;09DIAJ4642;09DIAJ2790;09DIAI8746;09DIAI7925;09DIAI6004;09DIAI4991;09DIAI3181;09DIAI2161;09DIAI0015;09DIAH8793;09DIAH7191;09DIAH5965;09DIAJ1752
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity	18 units
Recall Number	B-1747-12

Class II Devices Event

Event ID	57350
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Nov-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Pride Mobility Products Corp
City	Exeter
State	PA
Country	US
Distribution Pattern	Worldwide Distribution

Associated Products

Product Description	Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
Code Info	SC609PS SD514509149FV0 SD514609080FV0 SD514609059FV0 SD514509207FV0 SD514509251FV0 SD514609113FV0 SD514609133FV0 SD514509186FV0 SD514509246FV0 SD520809132FV0 SD514609024FV0 SD514509188FV0 SD514609020FV0 SD502010082030 SD502010080030 SD502010084030 SD514509181FV0 SD514509240FV0 SD514609141FV0 SD514609030FV0 SD525409018030 SD514609005FV0 SD514609007FV0 SD514509194FV0 SD514609119FV0 SD514509222FV0 SD514609135FV0 SD520809138FV0 SD520809037FV0 SD514509211FV0 SD514609009FV0 SD514509197FV0 SD514509164FV0 SD514509223FV0 SD514509195FV0 SD514609067FV0 SD514609034FV0 SD514509210FV0 SD514609081FV0 SD520809048FV0 SD514509171FV0 SD520809076FV0 SD514509153FV0 SD514509156FV0 SD514509160FV0 SD514509231FV0 SD514509250FV0 SD514509157FV0 SD514509151FV0 SD514509150FV0 SD514609112FV0 SD514509169FV0 SD514609106FV0 SD514609087FV0 SD514609116FV0 SD514509176FV0 SD514609120FV0 SD514609013FV0 SD514609118FV0 SD514509274FV0 SD526409032030 SD514609102FV0 SD514609027FV0 SD514609041FV0 SD514609051FV0 SD514609134FV0 SD514509199FV0 SD514609083FV0 SD514609049FV0 SD514609055FV0 SD514609077FV0 SD514509203FV0 SD514509249FV0 SD514509183FV0 SD514509189FV0 SD520809119FV0 SD514609076FV0 SD514509158FV0 SD514509184FV0 SD514609084FV0 SD514509147FV0 SD520809042FV0 SD514509201FV0 SD514609026FV0 SD514509258FV0 SD533509010030 SD514609125FV0 SD514509154FV0 SD514609074FV0 SD514609054FV0 SD514609057FV0 SD520809134FV0 SD514609075FV0 SD514609008FV0 SD514509255FV0 SD514509187FV0 SD514609052FV0 SD514609079FV0 SD514509200FV0 SD514509272FV0 SD514609111FV0 SD514609082FV0 SD514609115FV0 SD514609021FV0 SD514609017FV0 SD514609035FV0 SD514609038FV0 SD514609063FV0 SD514509213FV0 SD514609062FV0 SD514509218FV0 SD514609060FV0 SD514509202FV0 SD514609036FV0 SD514509206FV0 SD514609031FV0 SD514509185FV0 SD514509152FV0 SD514609091FV0 SD514609100FV0 SD514609064FV0 SD514609045FV0 SD514509248FV0 SD514609129FV0 SD514509172FV0 SD514609128FV0 SD514609016FV0 SD514609117FV0 SD514509216FV0 SD514509268FV0 SD514609033FV0 SD514509148FV0 SD514609140FV0 SD520809113FV0 SD514609109FV0 SD514609056FV0 SD502110014030 SD514609122FV0 SD514609043FV0 SD520809136FV0 SD514509196FV0 SD514609078FV0 SD514509205FV0 SD514509243FV0 SD514509275FV0 SD520809041FV0 SD514509229FV0 SD527409028030 SD514609126FV0 SD514609085FV0 SD514609138FV0 SD514609006FV0 SD520809100FV0 SD514609028FV0 SD514609010FV0 SD526509020030 SD526509018030 SD514509271FV0 SD514509177FV0 SD514609061FV0 SD514509198FV0 SD514509266FV0 SD514509232FV0 SD514509233FV0 SD514609094FV0 SD514609073FV0 SD520809081FV0 SD514509182FV0 SD514509242FV0 SD514609086FV0 SD514509190FV0 SD514509212FV0 SD514609105FV0 SD514609023FV0 SD514609029FV0 SD514509173FV0 SD514609002FV0 SD514509204FV0 SD514509170FV0 SD514609107FV0 SD514509238FV0 SD514609019FV0 SD514509163FV0 SD536409020030
Classification	Class II
Reason for Recall	The main harness connector was manufactured without the required back shield sealing protection. As a result, there is the potential for water to seep through the nonconforming harness.
Product Quantity	186
Recall Number	Z-1941-2012

Class II Biologics Event

Event ID	57770
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Dec-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Delta Blood Bank
City	Stockton
State	CA
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128710063798
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity	1 unit
Recall Number	B-2025-12

Class II Biologics Event

Event ID	60076
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Aug-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Surgical Tissue Network, Inc. dba TissueNet
City	Orlando
State	FL
Country	US
Distribution Pattern	Products were distributed to NJ, TX, NH, NY, PR; and to Turkey, Korea, and Chile.

Associated Products

Product Description	UltraC1 or C2, Cervical is labeled in part: "*ExpirationFreeze Dried: Store at 10 C - 37 CSterilization Method: T106 Terminal Sterilization SystemDonated Human Tissue Allograft / Sterile {SAL 10-6, Non-IrradiatedSingle Patient Use Only". Small label: "ID:UltraC1, CervicalFD57506, 6mm Small label: "ID:UltraC1, CervicalFD57507, 7mm Small label: "ID:UltraC1, CervicalFD57508, 8mm Small label: "ID:UltraC2, Cervical*FD57607, 7mm
Code Info	Product ID: FD57506, 6mm TN4211610002, TN4211610003, TN4211610004, TN4211610005, TN4211610006 TN4211610007, TN4211610008 Product ID: FD57507, 7mm TN4211610009, TN4211610010, TN421161001, TN4211610012, TN4211610013 TN4211610014 Product ID: FD57508, 8mm TN4211610015 Product ID: FD57607, 7mm TN4211610029, TN4211610030, TN4211610031, TN4211610032, TN4211610033
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	19 ea
Recall Number	B-1637-12

Product Description	Cancellous Crushed is labeled in part: "*Tissue ID:Description: Cancellous CrushedSize 15cc-4mm-10mmProduct Code FD55315RExpirationFreeze Dried: Store at 10 C - 37 CSterilization Method: T106 Terminal Sterilization SystemDonated Human Tissue Allograft / Sterile {SAL 10-6, Non-IrradiatedSingle Patient Use Only". Small label: "ID:Cancellous CrushedFD55315R EXP:TissueNet 800-465-8800**"
Code Info	Product ID: TN4211610036, TN4211610037, TN4211610038, TN4211610039, TN4211610040, TN4211610041, TN4211610042, TN4211610043, TN4211610044, TN4211610045, TN4211610046, TN4211610047, TN4211610048, TN4211610049, TN4211610050
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	15 ea
Recall Number	B-1638-12

Product Description	Cancellous Crushed is labeled in part: "*Tissue ID:Description: Cancellous CrushedSize 30cc-4mm-10mmProduct Code FD55330RExpirationFreeze Dried: Store at 10 C - 37 CSterilization Method: T106 Terminal Sterilization SystemDonated Human Tissue Allograft / Sterile {SAL 10-6, Non-IrradiatedSingle Patient Use Only". Small label: "ID:Cancellous CrushedFD55330R EXP:TissueNet 800-465-8800**"
Code Info	Product ID: TN4211610051, TN4211610052, TN4211610053, TN4211610054, TN4211610055, TN4211610056, TN4211610057, TN4211610058, TN4211610059, TN4211610060, TN4211610061, TN4211610062, TN4211610063, TN4211610064, TN4211610065
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	15 ea
Recall Number	B-1639-12

Product Description	Ultrafill DBM Human is labeled in part: "*Tissue ID:Description: Ultrafill DBM HumanSize 10ccProduct Code HM53010ExpirationFreeze Dried: Store at 10 C - 37 CSterilization Method: T10^6 (r)minal Sterilization SystemDonated Human Tissue Allograft / Sterile {SAL 10-6, Non-IrradiatedSingle Patient Use Only". Small label: "ID:Ultrafill DBM HumanHM53010 EXP:TissueNet 800-465-8800**"
Code Info	Product ID: TN4211610093, TN4211610094, TN4211610095, TN4211610096, TN4211610097
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	5 ea
Recall Number	B-1640-12

Product Description	Ultrafill DBM Human is labeled in part: "*Tissue ID:Description: Ultrafill DBM HumanSize 5ccProduct Code HM53005ExpirationFreeze Dried: Store at 10 C - 37 CSterilization Method: T10^6 (r)minal Sterilization SystemDonated Human Tissue Allograft / Sterile {SAL 10-6, Non-IrradiatedSingle Patient Use Only". Small label: "ID:Ultrafill DBM HumanHM53005 EXP:TissueNet 800-465-8800**"
Code Info	Product ID: TN4211610098, TN4211610099, TN4211610100, TN4211610101, TN4211610102, TN4211610103, TN4211610104, TN4211610105, TN4211610106, TN4211610107
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	10 ea
Recall Number	B-1641-12

Product Description	Mineralized Bone is labeled in part: "*Processed by: TissueNet7022 TPC Dr Ste 400Orlando, FL 32822Sterilized By: T106^(r) {SAL 10-6}Tissue ID:Description: Mineralized BoneSize 5ccProduct Code MB50050ExpirationFreeze Dried: Store at 10 C - 37 CDonated Human Tissue AllograftSingle Patient Use Only**". Full Product Description: Mineralized Bone .125-.85mm 5cc
Code Info	Product ID: TN4211610153, TN4211610154, TN4211610155, TN4211610156, TN4211610158, TN4211610159, TN4211610160, TN4211610161, TN4211610162, TN4211610163, TN4211610164, TN4211610165, TN4211610166, TN4211610167, TN4211610168, TN4211610169, TN4211610170, TN4211610171, TN4211610172, TN4211610173, TN4211610174, TN4211610175, TN4211610176, TN4211610177, TN4211610178, TN4211610179, TN4211610180
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	27 ea
Recall Number	B-1642-12

Product Description	Fashioned UltraBTB is labeled in part: "*Sterile {SAL 10-6} T106 Terminal Sterilization SystemTissue ID:Description Fashioned UltraBTBSizeProduct Code FF99050EXPIRATION:Store at -40 c or CoolerDonated Human Tissue AllograftSingle Patient Use OnlyID:Fashioned UltraBTBFF99050 EXP:TissueNet 800-465-8800*" Full Product Description: Fashioned UltraBTB 10x10mm
Code Info	Product ID: TN4211610073, TN4211610074, TN4211610075, TN4211610076
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	4 ea
Recall Number	B-1643-12

Product Description	Fashioned UltraAchilles is labeled in part: "*Sterile {SAL 10-6} T106 Terminal Sterilization SystemTissue ID:Description Fashioned UltraAchillesSizeProduct Code FF94355EXPIRATION:Store at -40 c or CoolerDonated Human Tissue AllograftSingle Patient Use OnlyID:Fashioned UltraAchillesFF94355 EXP:TissueNet 800-465-8800*" Full Product Description: Fashioned Achilles 9mm
Code Info	Product ID: TN4211610071, TN4211610072
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-1644-12

Product Description	UltraTibialis (Anterior) is labeled in part: "*Sterile {SAL 10-6} T106 Terminal Sterilization SystemTissue ID:Description UltraTibialis (Anterior)SizeProduct Code FF84230EXPIRATION:Store at -40 c or CoolerDonated Human Tissue AllograftSingle Patient Use OnlyID:UltraTibialis (Anterior) FF84230 EXP:TissueNet 800-465-8800*" Full Product Description: Ultra Tibialis Anterior
Code Info	Product ID: TN4211610077, TN4211610078
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2 ea
Recall Number	B-1645-12

Product Description	UltraP (Peroneus Longus) is labeled in part: "*Sterile {SAL 10-6} T106 Terminal Sterilization SystemTissue ID:Description UltraP (Peroneus Longus)SizeProduct Code FF93500EXPIRATION:Store at -40 c or CoolerDonated Human Tissue AllograftSingle Patient Use OnlyID:UltraP (Peroneus Longus)FF93500 EXP:TissueNet 800-465-8800*" Full Product Description: Ultra Peroneus Longus
Code Info	Product ID: TN4211610079, TN4211610080
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2 ea
Recall Number	B-1646-12

Product Description	Ultra Tibialis (Posterior) is labeled in part: "*Sterile {SAL 10-6} T106 Terminal Sterilization SystemTissue ID:Description Ultra Tibialis (Posterior)SizeProduct Code FF84231EXPIRATION:Store at -40 c or CoolerDonated Human Tissue AllograftSingle Patient Use OnlyID:Ultra Tibialis (Posterior)FF84231 EXP:TissueNet 800-465-8800*" Full Product Description: Ultra Tibialis Posterior
Code Info	Product ID: TN4211610081, TN4211610082
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2 ea
Recall Number	B-1647-12

Product Description	Ultra Semi-T (Semitendinosus) is labeled in part: "*Sterile {SAL 10-6} T106 Terminal Sterilization SystemTissue ID:Description Ultra Semi-T (Semitendinosus)SizeProduct Code FF83100EXPIRATION:Store at -40 c or CoolerDonated Human Tissue AllograftSingle Patient Use OnlyID:Ultra Semi-T (Semitendinosus)FF83100 EXP:TissueNet 800-465-8800*"
Code Info	Product ID: TN4211610083, TN4211610084
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2 ea
Recall Number	B-1648-12

Product Description	Fascia Lata, Large is labeled in part: "*Tissue ID:Description: Fascia Lata, LargeSize:Product dimensionProduct Code FD73520EXPIRATIONFreeze Dried: Store at 10 c - 37 cSterilization Method: T106 Terminal Sterilization systemDonated Human Tissue Allograft / Sterile {SAL 10-6, Non-IrradiatedSingle Patient Use OnlyID:Fascia Lata, LargeFD73520 EXP:TissueNet 800-465-8800**"
Code Info	Product ID: TN4211610087, TN4211610088
Classification	Class II
Reason for Recall	Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2 ea
Recall Number	B-1649-12

Class II Biologics Event

Event ID	60112
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Sep-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Allograft Innovations, LLC
City	Gainesville
State	FL
Country	US
Distribution Pattern	Affected products were distributed to Israel, South Korea, United Kingdom , Turkey and domestically to TX, FL, MI, IN, NJ, IL, MO AZ, OK, OK and WI.

Associated Products

Product Description	Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" .25-.5mm 15cc Cancellous Chips, Product Code 0306Al
Code Info	Tissue ID/Donor ID# Al1000082005 and Al1000082006
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-1625-12

Product Description	Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" .5-1mm 15cc, 30cc, and 1cc Cancellous Chips: Product Code 0308Al, .5-1mm 15cc Cancellous Chips Product Code 0309AI, .5-1mm 30cc Cancellous Chips Product Code 0326AI, .5-1mm 1cc Cancellous Chips
Code Info	Tissue ID/Donor ID# Al1000082007, Al1000082008, Al1000082009, Al1000082010, Al1000082011, Al1000112020, Al1000112021, Al1000112022, Al1000112023, Al1000112024, Al1000112025, Al1000112026, Al1000112027, Al1000112028, Al1000112029
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	15
Recall Number	B-1626-12

Product Description	Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" 1-4mm 15cc, 30cc, and 60cc Cancellous Chips Product Code 0310Al, 1-4mm 15cc Cancellous Chips Product Code 0311AI, 1-4mm 30cc Cancellous Chips Product Code 0313AI, 1-4mm 60cc Cancellous Chips
Code Info	Tissue ID/Donor ID: Al1000082012, Al1000082013, Al1000082014, Al1000082015, Al1000082016, Al1000082017, Al1000082018, Al1000082019, Al1000082020, Al1000082021, Al1000082022, Al1000082023, Al1000112014, Al1000112015, Al1000112016, Al1000112017, Al1000112018, Al1000112019
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	18
Recall Number	B-1627-12

Product Description	Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" 4-10mm 15cc, 30cc, and 60cc Cancellous Chips: Product Code 0317AI, 4-10mm 15cc Cancellous Chips Product Code 0318Al, 4-10mm 30cc Cancellous Chips Product Code 0320Al. 4-10mm 60cc Cancellous Chips
Code Info	Tissue ID/Donor ID: Al1000082024, Al1000082025, Al1000082026, Al1000082027, Al1000082028, Al1000082029, Al1000112030, Al1000112005, Al1000112006, Al1000082031, Al1000082032, Al1000082033, Al1000082034, Al1000112007, Al1000112008, Al1000112009, Al1000112010, Al1000112011, Al1000112012, Al1000112013
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	20
Recall Number	B-1628-12

Product Description	Achilles with Bone Block. "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 0201Al
Code Info	Donor#/Tissue ID# A1000110005 and Al1000110006
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-1629-12

Product Description	Patella Hemi. "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 1901Al
Code Info	Donor#/Tissue ID# A1000110008
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	1 Tissue
Recall Number	B-1630-12

Product Description	Patella Hemi Pre-Sized. "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 1903Al
Code Info	Donor#/Tissue ID# A1000110009
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	1 Tissue
Recall Number	B-1631-12

Product Description	Tibialis Anterior "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 2701Al
Code Info	Donor#/Tissue ID# A1000110010 and A1000110011
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-1632-12

Product Description	Tibialis Posterior "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 2702Al Donor#/Tissue ID# A100011-0012 and A100011-0013.
Code Info	Donor#/Tissue ID# A1000110012 and A1000110013
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-1633-12

Product Description	Peroneous Longus "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 2101Al
Code Info	Donor#/Tissue ID# A1000110014 and A1000110015
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-1634-12

Class II Devices Event

Event ID	61555
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Invacare Corporation
City	Elyria
State	OH
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Puerto Rico and the countries of Australia, Germany, New Zealand.

Associated Products

Product Description	TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position.
Code Info	TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, and FDX-MCG.
Classification	Class II
Reason for Recall	Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse.
Product Quantity	665 affected power wheel chairs and 15 post-fuse assembly service parts have been identified.
Recall Number	Z-1905-2012

Class II Devices Event

Event ID	61749
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	DePuy Orthopaedics, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

Associated Products

Product Description	ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall Number	Z-1906-2012

Product Description	ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall Number	Z-1907-2012

Product Description	ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall Number	Z-1908-2012

Product Description	ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 853154 and Lot numbers: 438751, 438880, 633705, XCU43, and XFE21
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall Number	Z-1909-2012

Product Description	ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall Number	Z-1910-2012

Product Description	ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 853156 and Lot numbers: 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall Number	Z-1911-2012

Product Description	ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 853157 and Lot numbers: 475235, 639640, 640919, 662465, XBK76, XCE42, XCU47, XEW27, XFE23, XFX43, XHL13, YAX30, YDW82, YEK32, YFE46, and YKK07.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall Number	Z-1912-2012

Product Description	ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 853158 and Lot numbers: 550633, 642337, XDG35, XDG36, XED10, XFE24, XHL14, XHL15, YAX31, and YGN25.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall Number	Z-1913-2012

Product Description	ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 853159 and Lot numbers: 438756, 438885, 577073, 633711, 660443, 663756, and XCE43.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall Number	Z-1914-2012

Product Description	LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code: 152180001 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1915-2012

Product Description	LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code:152180002 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1916-2012

Product Description	LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code:152180003 and Lot numbers: A46D71000, A52C11000, A88D11000, AY2CE1000, B1XGV1000, BA3BF1000, BC6BC1000, BX9B71000, Y97FM1000, and Z5NBJ1000.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1917-2012

Product Description	LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code:152180004 and Lot numbers: A4VCX1000, A55MG1000, A88F41000, AT4FH1000, BC5E51000, BJ4JP1000, BS3FN1000, BX9B81000, and ZV1FH1000.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	Eighty-five (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1918-2012

Product Description	LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code:152180005 and Lot numbers: AH7DVA000 and VJ3B21003.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1919-2012

Product Description	LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code:152180006 and Lot numbers: A21BR1000, A4CD61000, AR1C81000, BB8E31000, V2RCB1005, W4GCP1007, WR6EXA000, WS3GX1003, X5SFN1000, X68GE1000, Y47BLA000, Y4HA21000, Z1TD71000, and Z66H41000.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1920-2012

Product Description	LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code:152180007 and Lot numbers: A1XEF1000, A21BV1000, A4NBV1000, A6BB31000, AB1H31000, AV1A71000, AV7FL1000, BB8E21000, BV8FT1000, VG3BSB000, X5XD21000, Y64ET1000, Z12DG1000, and Z1PJE1000.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1921-2012

Product Description	LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code:152180008 and Lot numbers: A5BDJ1000, A73C51000, AH6D21000, X4GBW1000, and Z2YCR1000.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1922-2012

Product Description	LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code:152180009 and Lot numbers: AE9GG1000, AH7DW1000, U5TA2C000, V1YEE1001, W1CBL1001, W5RF41001, W5RF41007, and Y84DW1000.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1923-2012

Product Description	LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Info	Product code:152180010 and Lot numbers: A4VCY1000 and T76A61007.
Classification	Class II
Reason for Recall	DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity	85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall Number	Z-1924-2012

Class II Drugs Event

Event ID	61871
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Teva Pharmaceuticals USA, Inc.
City	Sellersville
State	PA
Country	US
Distribution Pattern	Ohio

Associated Products

Product Description	Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10
Code Info	Lot #TE1Y261, Exp, 12/2013
Classification	Class II
Reason for Recall	Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Product Quantity	2,268 bottles
Recall Number	D-1409-2012

Class II Devices Event

Event ID	61874
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	DePuy Mitek, Inc., a Johnson & Johnson Co.
City	Raynham
State	MA
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.

Associated Products

Product Description	Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Code Info	All lots
Classification	Class II
Reason for Recall	Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product Quantity	683 units
Recall Number	Z-1937-2012

Product Description	Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Code Info	All lots
Classification	Class II
Reason for Recall	Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product Quantity	704 units
Recall Number	Z-1938-2012

Product Description	Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Code Info	All lots
Classification	Class II
Reason for Recall	Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product Quantity	530 units
Recall Number	Z-1939-2012

Product Description	Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Code Info	All lots
Classification	Class II
Reason for Recall	Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product Quantity	6979 units
Recall Number	Z-1940-2012

Class II Devices Event

Event ID	61998
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Microbiologics Inc
City	Saint Cloud
State	MN
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, KY, ME, MA, MI, MN, MS, NJ, NM, NY, PA, PR, SC, TX, VT, and VA. and the countries of SWITZERLAND, ITALY, ISRAEL, IRELAND, COLOMBIA, SWEDEN, INDIA, SINGAPORE, SERBIA, SAUDI ARABIA, CANADA, TAIWAN, SOUTH AFRICA, FRANCE, BRAZIL, MALTA, MACEDONIA, MALAYSIA, FINLAND, ECUADOR, VENEZUELA, REPUBLIC OF KOREA, NETHERLANDS, PERU, UNITED ARAB EMERITES, TURKEY, POLAND, and LEBANON.

Associated Products

Product Description	Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms populations of known and predictable characteristics. These slide support formal quality assurance programs by serving as quality control challenges to demonstrate and document satisfactory performance of staining regents and methods used in staining procedures and to document personnel's ability to perform the procedure and to properly interpret the microscopic test results.
Code Info	0353 - 0355, 0357 - 0363
Classification	Class II
Reason for Recall	Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative control organism (E.coli) is not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could potentially lead to misdiagnosis and improper treatment of a patient.
Product Quantity	13,720 slides (10 slides per box)
Recall Number	Z-1936-2012

Class II Food/Cosmetics Event

Event ID	62003
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Tree Top Inc - Selah Plant
City	Selah
State	WA
Country	US
Distribution Pattern	Shipped to accounts in VA and IA.

Associated Products

Product Description	Pear juice concentrate 70 Brix in 55 gallon steel drums with plastic liner that are filled to 52 gallons. Labeled in part: "CLAREX PEAR JUICE CONCENTRATE "cRc-KOSHER"*52 GALLONS" and "TREE TOPPEAR CONCENTRATE TYPE IIIRESOURCE #: 4200815003Selah, Wa. 98942MADE IN USA*".
Code Info	Lot numbers: "9321012001" and "9321012002"
Classification	Class II
Reason for Recall	The product contains in excess of 23 ppb inorganic arsenic which exceeds the FDA published level of concern for a chronic exposure.
Product Quantity	6708 gallons
Recall Number	F-1683-2012

Class II Food/Cosmetics Event

Event ID	62057
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ultradent Products, Inc.
City	South Jordan
State	UT
Country	US
Distribution Pattern	Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.

Associated Products

Product Description	Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419.
Code Info	Lot numbers: 112933, B5N16, B5PHZ, B5PZN, B5R5Y, B5TRB, B5VY1, B5WQQ, B5Z3J, B65QW, B68MW, B6CG1, B6GTW, B6HPK, B6K7Y, B6NKD, B6T39, B6XCN.
Classification	Class II
Reason for Recall	Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.
Product Quantity	17, 889 cartons
Recall Number	F-1708-2012

Product Description	Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.
Code Info	Lot numbers: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9.
Classification	Class II
Reason for Recall	Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.
Product Quantity	4,083 units
Recall Number	F-1709-2012

Product Description	Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8418.
Code Info	Lot numbers: B6Y7B.
Classification	Class II
Reason for Recall	Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement. They are also recalling a single lot of spearmint flavored gum as it was accidentally manufactured with cinnamon flavored product.
Product Quantity	668 units
Recall Number	F-1710-2012

Class II Food/Cosmetics Event

Event ID	62126
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Jun-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Pendleton Flour Mills, Llc
City	Blackfoot
State	ID
Country	US
Distribution Pattern	Product was distributed to three consignees in CA, OR and UT.

Associated Products

Product Description	Wheat Germ, brand name PFM, package in bulk tote, approximately 1650 lbs. per tote. Product SKU is 1344.
Code Info	Date of Manufacture: 2/16/12, 2/17/12, 2/18/12, 2/19/12, 2/20/12, 2/21/12.
Classification	Class II
Reason for Recall	Wheat germ product is contaminated with metal fragments, approximately 0.5mm in diameter and range 3-15mm in length.
Product Quantity	16 totes (approximately 25,061 lbs)
Recall Number	F-1686-2012

Class II Devices Event

Event ID	62137
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Zimmer, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.

Associated Products

Product Description	PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
Code Info	Part number 3564-1; all lots
Classification	Class II
Reason for Recall	Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and material missing. There were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events were filed as MDR reports since the location of the fi'agments from the broken set screw were unknown.
Product Quantity	77 units
Recall Number	Z-1933-2012

Class II Devices Event

Event ID	62240
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Aesculap Implant Systems LLC
City	Center Valley
State	PA
Country	US
Distribution Pattern	Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .

Associated Products

Product Description	S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Code Info	All distributed lot numbers and serial numbers
Classification	Class II
Reason for Recall	Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
Product Quantity	15
Recall Number	Z-1934-2012

Class II Devices Event

Event ID	62270
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Healthcare Inc.
City	Andover
State	MA
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of Argentina, Chile, Denmark , Estonia, Finland, France, Germany ,Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan, United Kingdom, and Utd. Arab. Emir.

Associated Products

Product Description	Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.
Code Info	Software R2.1 L 1 SP2
Classification	Class II
Reason for Recall	Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
Product Quantity	226 units
Recall Number	Z-1942-2012

Class II Devices Event

Event ID	62283
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Jun-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Thayer Medical Corporation
City	Tucson
State	AZ
Country	US
Distribution Pattern	Worldwide Distribution - USA including CA, KY and Europe.

Associated Products

Product Description	AirLife® MiniSpacer® MDI Dispenser Adapter. Dual-Spray MiniSpacer® Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer® is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The MiniSpacer is not a metering valve, and does not measure the amount of medication dispensed. The device may also be used in conjunction with a resuscitator bag or in-line with cool or heated humidification, oxygen enriched T-pieces (blow-by) systems connected to tracheal/endotracheal tube. Environments of use include short and long term critical care settings. The 15 mm Dual Spray MiniSpacers design provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs it through the dual orifices into the airstream. Principles of Operation A healthcare practitioner installs the 15 mm MiniSpacer MDI adapter in the breathing circuit, according to facility procedures or as ordered by a physician or other licensed health care practitioner. To dispense the prescribed medication, the healthcare practitioner inserts the MDI canister stem into the devices actuator port and manually depresses the MDI canister. The MDI canisters metering valve releases the combination of medication and propellant through the valve stem and out of the devices dual spray nozzle. The plume is simultaneously ejected through upstream and downstream spray orifices along the longitudinal axis of the device. The practitioner administers the medication as prescribed, caps the MiniSpacer device, and monitors the patient response. The devices are packaged in cardboard corrugated cartons that are rated to meet burst testing up to 200 pounds per square inch. Each carton contains 30 devices; each device is packaged in a polybag with the instructions for use. These devices are sold non-sterile.
Code Info	PRODUCT CODES Affected Lot Number(s) (US): 120320, 120410 Affected Lot Number (EU only): 120405 Expiration Date: Not Applicable Serial Number: Not Applicable UPC Code (individual device): (01) 00885403167839 UPC Code (case): (01) 50885403167834 Brand Name: AirLife® MiniSpacer® MDI Dispenser Adapter Description: 15 mm O.D. / I.D. connections Catalogue Number: 002092 US Product Code: CAF FDA 510(k) Number: K955805
Classification	Class II
Reason for Recall	Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI) adapter that results in an incomplete fill of the aerosol dispensing pathway.
Product Quantity	19340
Recall Number	Z-1927-2012

Class II Food/Cosmetics Event

Event ID	62309
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Newly Weds Foods Inc
City	Chicago
State	IL
Country	US
Distribution Pattern	California, Florida, Indiana, Maryland, Ohio, Tennessee and Texas

Associated Products

Product Description	Turkey Dripping Type Marinade X1, 50 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G00988
Code Info	product G00988, lot numbers YE303312 and MT618006
Classification	Class II
Reason for Recall	The products were manufactured using a roast meat flavor yeast extract recalled by DSM Nutritional Products, Llc. because it is contaminated with Salmonella.
Product Quantity	4,450 lbs.
Recall Number	F-1684-2012

Product Description	Firewood Grill Seasoning X2, 25 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G51189
Code Info	product G51189, lot numbers MT618160, MT618809, MT620049 and MT621951
Classification	Class II
Reason for Recall	The products were manufactured using a roast meat flavor yeast extract recalled by DSM Nutritional Products, Llc. because it is contaminated with Salmonella.
Product Quantity	6,600 lbs
Recall Number	F-1685-2012

Class II Drugs Event

Event ID	62350
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Feb-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	sanofi-aventis US, Inc.
City	Bridgewater
State	NJ
Country	US
Distribution Pattern	Nationwide.

Associated Products

Product Description	Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
Code Info	Lot number and expiration dates Eloxatin® (OXALIplatin injection) 50mg vial AE41 02/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial CA02B 02/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial AE27 02/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial BL18B 06/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial CB13B 06/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial CD65B 01/ 2014 Eloxatin® (OXALIplatin injection) 50mg vial CE39B 01/ 2014
Classification	Class II
Reason for Recall	CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Product Quantity	196,355 vials
Recall Number	D-1407-2012

Product Description	Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
Code Info	Lot number and expiration dates Eloxatin® (OXALIplatin injection) 100mg vial AD21 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AD22 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AE24 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AE25 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF55 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AE26 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF03 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF04 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF21 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BL19B 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CB11B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CB102B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CB12B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CA01B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BH07 06/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BH08 06/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BH09 06/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CC109B 01/ 2014
Classification	Class II
Reason for Recall	CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Product Quantity	387,738 vials
Recall Number	D-1408-2012

Class II Food/Cosmetics Event

Event ID	62385
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Seoul Shik Poom, Inc.
City	Englewood
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Frozen Oysters, Net Wt 1 LBS (454g). Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea.
Code Info	All Korean oysters that has the Choripdong Label on it.
Classification	Class II
Reason for Recall	Korean Certified Shippers delisted from ICSSL.
Product Quantity	412 cases
Recall Number	F-1713-2012

Product Description	Frozen Salted Clam, 12/210g. Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea.
Code Info	Frozen salted clam, 12/210g; Item # MB3023.
Classification	Class II
Reason for Recall	Korean Certified Shippers delisted from ICSSL.
Product Quantity	3 cases
Recall Number	F-1714-2012

Class II Food/Cosmetics Event

Event ID	62388
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Jun-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Healthy Choice/Island Blends, Inc. (dba Juice Connection)
City	Los Angeles
State	CA
Country	US
Distribution Pattern	Distribution within CA.

Associated Products

Product Description	Carrot juice. Labeling reads in part:"*LIQUID GOLD 24K CARROT JUICEJUICE CONNECTION LOS ANGELES CALIFORNIA 90058 7 62313 00130 0INGREDIENTS: PASTEURIZED CARROT JUICE**".
Code Info	UPC Code 7 63213 00130 0
Classification	Class II
Reason for Recall	The firm's carrot juice has the potential to be contaminated with Clostridium botulinum.
Product Quantity	118 gallons
Recall Number	F-1707-2012

Class II Food/Cosmetics Event

Event ID	62417
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jun-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	SR Rosati, Inc
City	Clifton Heights
State	PA
Country	US
Distribution Pattern	Product was distributed within the United States to AL, DE, GA, MA, MI, NC, and VA. Approximately 75% is still within the firm's control.

Associated Products

Product Description	Rosati Cry Baby Sour Watermelon water ice, 6 fl oz
Code Info	Lot N08670
Classification	Class II
Reason for Recall	Product label does not declare FD&C Yellow #5
Product Quantity	4,608 cases of 12/6 oz cups
Recall Number	F-1712-2012

Class II Food/Cosmetics Event

Event ID	62424
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jun-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Cedars Bakery
City	Dearborn
State	MI
Country	US
Distribution Pattern	retail bakery and restaurants in Wayne, Oakland and Macomb counties of Michigan

Associated Products

Product Description	Cedar's Bakery Pita Bread, 10 loaves, White; ingredients flour water,yeast, sugar, salt. Nt. Wt. 22 oz.(1 lb. 6 oz. - 624 GMs)
Code Info	none
Classification	Class II
Reason for Recall	Cedar's Bakery White Pita Bread, does not list the source of the flour ingredient as wheat, an allergen.
Product Quantity	~ 700 bags
Recall Number	F-1711-2012

Class II Devices Event

Event ID	62447
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Greiner Bio-One North America, Inc.
City	Monroe
State	NC
Country	US
Distribution Pattern	Nationwide Distribution including IL, MS, OH, PA, TN and VA.

Associated Products

Product Description	Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
Code Info	Item #450239, Lot #G110601I and Item #450235, Lot #G110302J.
Classification	Class II
Reason for Recall	: The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.
Product Quantity	19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
Recall Number	Z-1935-2012

Class II Food/Cosmetics Event

Event ID	62458
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jun-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Seoul Trading Inc.
City	Auburn
State	WA
Country	US
Distribution Pattern	Products were distributed to Oregon and Washington

Associated Products

Product Description	Cho-Rip-Dong Frozen Oysters in plastic bags: 1) Item no. BG1501, net wt. 1 lb.; 2) Item no. BG1521, net wt. 8 oz.; 3) Item no. BG1551, net wt. 3 lb.; 4) Item no. BG1601, net wt. 10 lb.; 5) Item no. BG1631, net wt. 1 lb.
Code Info	unknown
Classification	Class II
Reason for Recall	Korean oysters have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	1)150 cases/; 2) 180 cases; 3) 90 cases; 4) 100 cases; 5) 60 cases
Recall Number	F-1717-2012

Product Description	Nol-Boo Global Frozen Rice Cake & Mussel, Item no. EN5011, package in a plastic bag, net wt. 1.21 lb.
Code Info	expiration date: 04/17/2013
Classification	Class II
Reason for Recall	product containing mussel has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	20 cases/8 pkg/1.21 lb
Recall Number	F-1718-2012

Product Description	Na-Rae NR, Salted & Fermented Oyster, item no. MA1159, net wt. 44 lb per case. Cho-Rip-Dong Salted & Fermented Oyster, item no. MB3025, net wt. 7.4 oz per bag.
Code Info	expiration date: 09/23/2013
Classification	Class II
Reason for Recall	product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	33 cases/44 lbs and 3 cases/12 pkg/7.4 oz.
Recall Number	F-1719-2012

Class III Biologics Event

Event ID	57375
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Sep-10
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Delta Blood Bank
City	Stockton
State	CA
Country	US
Distribution Pattern	CA, Austria

Associated Products

Product Description	Recovered Plasma
Code Info	W128710068173
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose arm inspection was not documented, were distributed.
Product Quantity	1 unit
Recall Number	B-2026-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128710068173
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose arm inspection was not documented, were distributed.
Product Quantity	1 unit
Recall Number	B-2027-12

Class III Devices Event

Event ID	61525
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Integra LifeSciences Corp. d.b.a. Integra Pain Management
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Nationwide Distribution including MA

Associated Products

Product Description	Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.
Code Info	Lot W1112119
Classification	Class III
Reason for Recall	Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Product Quantity	4 cases x 10 units per case
Recall Number	Z-1943-2012

Class III Drugs Event

Event ID	61872
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
City	Fort Washington
State	PA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
Code Info	Lot #CMF023, Expiration 07/13.
Classification	Class III
Reason for Recall	Defective Container; damaged blister units
Product Quantity	53,892 packages
Recall Number	D-1404-2012

Class III Food/Cosmetics Event

Event ID	61909
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	The Dannon Company Inc
City	Minster
State	OH
Country	US
Distribution Pattern	US distribution only: Illinois, Wisconsin and Minnesota.

Associated Products

Product Description	Dannon Fruit on the Bottom, Raspberry flavor. 6oz form fill seal cup yogurt with predominantly blue labelling.
Code Info	Lot code 63210
Classification	Class III
Reason for Recall	Routine testing by the firm showed the presence of Coliforms in absence of E. coli.
Product Quantity	1,350 cases for all products in Recall Event
Recall Number	F-1638-2012

Product Description	Dannon Fruit on the Bottom, Mixed Berry flavor. 6oz form fill seal cup yogurt with predominantly blue labelling.
Code Info	Lot code 63215
Classification	Class III
Reason for Recall	Routine testing by the firm showed the presence of Coliforms in absence of E. coli.
Product Quantity	1,350 cases for all products in Recall Event
Recall Number	F-1639-2012

Class III Drugs Event

Event ID	61934
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ranbaxy Inc.
City	Princeton
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08
Code Info	Lot #: RB81031, Exp 01/13
Classification	Class III
Reason for Recall	Subpotent (single Ingredient Drug): out of specification result for coal tar content assay.
Product Quantity	2544 bottles
Recall Number	D-1405-2012

Class III Biologics Event

Event ID	62079
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160060733; 2160062847; 2160065473;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1809-12

Class III Biologics Event

Event ID	62080
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160069344;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1810-12

Class III Biologics Event

Event ID	62081
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160072103; 2160076211;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1811-12

Class III Biologics Event

Event ID	62082
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160082721; 2160071425; 2160073352; 2160076030;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	4
Recall Number	B-1812-12

Class III Biologics Event

Event ID	62083
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160067524; 2160078501; 2160079479; 2160081725; 2160084136; 2160059822; 2160064134; 2160065636;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	8
Recall Number	B-1813-12

Class III Biologics Event

Event ID	62084
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160060189; 2160061770; 2160062511;
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1814-12

Class III Biologics Event

Event ID	62085
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160077043; 2160077514; 2160062372; 2160064154; 2160074491;
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	5
Recall Number	B-1815-12

Class III Biologics Event

Event ID	62086
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160064423; 2160069367; 2160069826; 2160079559;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	4
Recall Number	B-1816-12

Class III Biologics Event

Event ID	62087
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160061447; 2160071525; 2160082452;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1817-12

Class III Biologics Event

Event ID	62088
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160077149;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1818-12

Class III Biologics Event

Event ID	62089
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160077746; 2160082719;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2 units
Recall Number	B-1819-12

Class III Biologics Event

Event ID	62090
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160081717; 2160083398;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1820-12

Class III Biologics Event

Event ID	62091
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160078530; 2160060203; 2160065145; 2160071517; 2160078190;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	5
Recall Number	B-1821-12

Class III Biologics Event

Event ID	62092
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160074168; 2160078344;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1822-12

Class III Biologics Event

Event ID	62093
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160059356; 2160059962;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1823-12

Class III Biologics Event

Event ID	62094
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-11
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160068577;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1824-12

Class III Biologics Event

Event ID	62095
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160066843;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1825-12

Class III Biologics Event

Event ID	62184
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160062308; 2160068966;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1843-12

Class III Biologics Event

Event ID	62185
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160081036;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1883-12

Class III Biologics Event

Event ID	62186
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160063498;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1884-12

Class III Biologics Event

Event ID	62187
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160059814; 2160067375;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1885-12

Class III Biologics Event

Event ID	62188
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160058180; 2160062907;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1886-12

Class III Biologics Event

Event ID	62189
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160073430;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1887-12

Class III Biologics Event

Event ID	62190
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160062987; 2160074078;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1888-12

Class III Biologics Event

Event ID	62191
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160063042; 2160063876;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1889-12

Class III Biologics Event

Event ID	62192
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160078137;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1890-12

Class III Biologics Event

Event ID	62193
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160064991; 2160069116; 2160070885;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1891-12

Class III Biologics Event

Event ID	62194
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160058966; 2160059586;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1892-12

Class III Biologics Event

Event ID	62196
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160079822; 2160080589;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1894-12

Class III Biologics Event

Event ID	62197
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160063733; 2160065091; 2160066720; 2160068524; 2160069915; 2160083083;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	6
Recall Number	B-1895-12

Class III Biologics Event

Event ID	62198
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160069116; 2160070885; 2160064991;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1896-12

Class III Biologics Event

Event ID	62200
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160078367; 2160073485; 2160069938; 2160067984; 2160081122; 2160082792; 2160069055;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	7
Recall Number	B-1898-12

Class III Biologics Event

Event ID	62201
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160072827;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1899-12

Class III Biologics Event

Event ID	62202
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160068777; 2160070279; 2160079153;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1900-12

Class III Biologics Event

Event ID	62203
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160059954; 2160073116;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1901-12

Class III Biologics Event

Event ID	62204
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160079113; 2160079445;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1902-12

Class III Biologics Event

Event ID	62205
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160057765;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1903-12

Class III Biologics Event

Event ID	62206
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160060981;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1904-12

Class III Biologics Event

Event ID	62207
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160076135; 2160076922; 2160077844;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1905-12

Class III Biologics Event

Event ID	62208
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160081453;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1906-12

Class III Biologics Event

Event ID	62209
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160064006; 2160075573; 2160076829; 2160061898;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	4
Recall Number	B-1907-12

Class III Biologics Event

Event ID	62210
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160082410;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1908-12

Class III Food/Cosmetics Event

Event ID	62289
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Aldi Inc
City	Batavia
State	IL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Northern Catch Harvest of the Sea Fancy Whole Oysters and SeaNet Fancy Whole Oysters; Net Wt. 8 oz (227g) cans, 12 cans per carton; Distributed by Aldi Inc., Batavia, IL 60510-1477; Product of Korea; UPC 0 41498 11984 3
Code Info	All lots of both brand names sold between February 20, 2009 and May 29, 2012
Classification	Class III
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	116,533 cartons
Recall Number	F-1724-2012

Class III Drugs Event

Event ID	62383
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Watson Laboratories Inc
City	Corona
State	CA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
Code Info	Lot 108094A
Classification	Class III
Reason for Recall	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity	8254 bottles
Recall Number	D-1399-2012

Product Description	Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01
Code Info	Lot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.
Classification	Class III
Reason for Recall	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity	106,323 bottles
Recall Number	D-1400-2012

Product Description	Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01
Code Info	Lot #s: 101696A, 110829A, 123685A, 123687A
Classification	Class III
Reason for Recall	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity	21,572 bottles
Recall Number	D-1401-2012

Product Description	Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
Code Info	Lot #s: 104432A, 104433A, 121344A, 127024A, 144290A
Classification	Class III
Reason for Recall	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity	18,902 bottles
Recall Number	D-1402-2012

Product Description	Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
Code Info	Lot # 22478A
Classification	Class III
Reason for Recall	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity	7,262 bottles
Recall Number	D-1403-2012

Class III Food/Cosmetics Event

Event ID	62438
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Mitsui Foods Inc
City	Norwood
State	NJ
Country	US
Distribution Pattern	Nationwide.

Associated Products

Product Description	Whole Oysters: 1) Empress Whole Oysters, NET WT 8 OZ. Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea, UPC 7360000719. 2) Premium Quality Private Selection Whole Oysters, NET WT 8 OZ. Distributed By Inter-American Products, Inc. Cincinnati, OH 45202. Product of Korea, UPC 111081484.
Code Info	Lot Numbers: 405046-006, 405046-007, 406639-005, 406670-004, 406716-001, 406781-004, 407995-001, 407995-003, 408080-001, 408080-002, 406443-001, 406639-002, 406639-004, 406777-001, 406780-001, 406780-003, 406781-003, 406639-001, 406639-003, 406639-006, 406777-002, 406670-002, and 407995-002.
Classification	Class III
Reason for Recall	As of May 1, Korean shellfish imports have been blocked by the United States because Korean waters may have been polluted. FDA said that all Korean certified shippers of molluscan shellfish were removed from the Interstate Certified Shellfish Shippers List. Therefore, FDA said that food distributors, retailers and food service operators should "remove from sale or service, all fresh, frozen and processed Korean molluscan shellfish and any product subsequently made with them." Out of an abundance of caution, Mitsui Foods is requesting the return of all Korean oyster product that you may have on hand.
Product Quantity	20,074 cases Empress products: 77,437 Private Select products
Recall Number	F-1715-2012

Product Description	Smoked Oysters: 1) Empress Smoked Oysters In Cottonseed Oil, NET WT 3.75 OZ. Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea, UPC7360000713. 2) Premium Quality Private Selection Smoked Oysters In Cottonseed Oil, NET WT 3.75 OZ. Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea. Farm Raised, UPC 111081484.
Code Info	Lot Numbers: 405046-006, 405046-007, 406639-005, 406670-004, 406716-001, 406781-004, 407995-001, 407995-003, 408080-001, 408080-002, 406443-001, 406639-002, 406639-004, 406777-001, 406780-001, 406780-003, 406781-003, 406639-001, 406639-003, 406639-006, 406777-002, 406670-002, and 407995-002.
Classification	Class III
Reason for Recall	As of May 1, Korean shellfish imports have been blocked by the United States because Korean waters may have been polluted. FDA said that all Korean certified shippers of molluscan shellfish were removed from the Interstate Certified Shellfish Shippers List. Therefore, FDA said that food distributors, retailers and food service operators should "remove from sale or service, all fresh, frozen and processed Korean molluscan shellfish and any product subsequently made with them." Out of an abundance of caution, Mitsui Foods is requesting the return of all Korean oyster product that you may have on hand.
Product Quantity	Private Select brand products: 77,437 cases; Empress 20,074
Recall Number	F-1716-2012

Class III Drugs Event

Event ID	62442
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Health Plus Incorporated
City	Chino
State	CA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
Code Info	Lot number 120502276, Expiration date 05/2015, UPC Code 08807/11/0 -- revision number 08807/11/0. Lot number 120201286, Expiration date 03/2015, UPC Code 08807/11/0.
Classification	Class III
Reason for Recall	Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.
Product Quantity	24,423 bottles
Recall Number	D-1406-2012

Mixed Classification Biologics Event

Event ID	62195
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160082085; 2160070284; 2160069890; 2160073365;
Classification	Class II
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	4
Recall Number	B-1893-12

Mixed Classification Food/Cosmetics Event

Event ID	62336
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mexicantown Wholesale
City	Detroit
State	MI
Country	US
Distribution Pattern	CANADA ONLY

Associated Products

Product Description	MUFFIN CHOCOCHIPS IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz
Code Info	UPC: 9564000029; and item #003 All products distributed on 5/15/2012.
Classification	Class I
Reason for Recall	The firm recalled 26 products for undeclared allergens. this product was recalled due to undeclared soy (soy four and soybean oil) and milk (nonfat milk).
Product Quantity	50 products (Canadian distribution only)
Recall Number	F-1689-2012

Product Description	MUFFIN PLAIN (MEXICAN SWEET BREAD) IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz, UPC: 9564000029; and item #001
Code Info	All products distributed on 5/15/2012.
Classification	Class I
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy flour and soybean oil).
Product Quantity	80 products (Canadian distribution only)
Recall Number	F-1690-2012

Product Description	Muffins with Pecans: 1) MUFFIN W/PECANS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4oz; UPC 9564000029, item #002; 2) MUFFIN W/PECANS MEXICAN SWEET BREAD IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz, UPC 9564000029; 3) MUFFINS W/PECANS (MEXICAN SWEET BREAD) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 4.0oz
Code Info	1) All products distributed on 5/15/2012; 2) all products distributed on 5/11/12; 3) all products distributed on 5/9/12 and 5/16/12
Classification	Class I
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy bean oil and soy flour).
Product Quantity	1) 50 products; 2) 200 3) 100 (Canadian distributed only)
Recall Number	F-1691-2012

Product Description	POLVORONES FRESA Y PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz
Code Info	UPC: 9564000016 All products distributed on 5/15/2012.
Classification	Class II
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #5, yellow #6 and red #40.
Product Quantity	40 products (Canadian distribution only)
Recall Number	F-1692-2012

Product Description	CONCHAS: 1) CONCHAS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz, UPC: 0895640000; and item #002; 2) CONCHAS (MEXICAN BREAD) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 4/4.0oz;, UPC 0895640000; 3) CONCHAS (MEXICAN BREAD) IMPORTED BY FIESTA WHOLESALE MISSISSAUGA ON. 416-833-5959 416-509-8349 4/4.0OZ, UPC 0895640000
Code Info	1) All products distributed on 5/15/2012. 2) All products distributed on 5/9/2012 and 5/16/12 3) All products distributed 5/9-16/2012
Classification	Class II
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6.
Product Quantity	1) 50 products; 2) 40; 3) 96(Canadian distribution only)
Recall Number	F-1693-2012

Product Description	CUERNOS: 1) CUERNOS/CROISSANT (MEXICAN SWEET BREAD/Pain sucre) IMPORTED BY MAX PRODUCTS LEAMINGTON 519-325-1176, 4 oz., UPC 9564000035; 2) CUERNOS PLAIN (MEXICAN SWEET BREAD/PAIN SUCRE) IMPORTED BY FIESTA WHOLESALE MISSISSAUGA ON. 416-833-5959 416-509-8349 4.0OZ, UPC: 9564000035
Code Info	1) All products distributed on 5/11/2012. 2) All products disbributed on 5/9/12 and 5/16/12.
Classification	Class II
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6.
Product Quantity	1) 200 products (Canada distributed only); 2) 12
Recall Number	F-1694-2012

Product Description	TACOS DE MANZANA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 3.4oz
Code Info	UPC: 9564000010; and item #002 All products distributed 5/15/2012.
Classification	Class III
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared SULFITES.
Product Quantity	7 products (Canada distribution only)
Recall Number	F-1695-2012

Product Description	MAGDALENAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
Code Info	UPC: 9564000019; and item #002 All products distributed on 5/15/2012.
Classification	Class II
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6.
Product Quantity	150 products (Canada distribution only)
Recall Number	F-1696-2012

Product Description	TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
Code Info	UPC: 9564000053; and item #002 All products distributed on 5/15/2012.
Classification	Class I
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (liquid milk added), FD&C yellow #6, and wheat (flour).
Product Quantity	10 products (Canada distribution only)
Recall Number	F-1697-2012

Product Description	MUFFINS CHOCOCHIPS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 24-MAY-12
Code Info	UPC: 9564000029 All products distributed on 5/10/12 and 5/17/2012.
Classification	Class I
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (nonfat milk), Soy (soybean oil and soy flour), FD&C yellow #6, and wheat (flour).
Product Quantity	6 products (Canada distribution only)
Recall Number	F-1698-2012

Product Description	MUFFINS PLAIN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 21-MAY-12
Code Info	UPC: 9564000029; and item #002 All products distributed on 5/10/12 and 5/17/2012.
Classification	Class I
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (nonfat milk), soy (soybean oil and soy flour), and wheat (flour).
Product Quantity	6 products(Canada distribution only)
Recall Number	F-1699-2012

Product Description	TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz
Code Info	UPC: 9564000053; and item #002 All products distributed on 5/10/12 and 5/17/2012.
Classification	Class II
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6.
Product Quantity	4 products (Canada distribution only)
Recall Number	F-1700-2012

Product Description	1) EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12, UPC: 9564000009 2) EMPANADAS DE PINA (MEXICAN SWEET BREAD/pain sucre) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 3.4oz
Code Info	1) All products distributed on 5/10/12 and 5/17/2012. 2) All products distributed on 5/9/12 and 5/16/12.
Classification	Class II
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6.
Product Quantity	1) 10 products; 2) 100 products (Canada distribution only)
Recall Number	F-1701-2012

Product Description	POLVORONES CON FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
Code Info	UPC: 9564000009 All products distributed on 5/10/12 and 5/17/2012.
Classification	Class II
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6 AND RED #40.
Product Quantity	10 products (Canada distribution only)
Recall Number	F-1702-2012

Product Description	EMPANADAS DE FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
Code Info	UPC: 9564000009 All products distributed on 5/10/2012 and 5/17/2012.
Classification	Class III
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared RED#40.
Product Quantity	8 products (Canada distribution only)
Recall Number	F-1703-2012

Product Description	CONCHAS (MEXICAN BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 4/4.0oz
Code Info	UPC: 0895640000 All products distributed on 5/11/2012.
Classification	Class II
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #5 and yellow #6.
Product Quantity	50 products (Canada distribution only)
Recall Number	F-1704-2012

Product Description	EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MANUFACTURED BY MEXICANTOWN WHOLESALE DETROIT MI 48210 3.4oz
Code Info	UPC: 9564000009 All products distributed on 5/11/2012.
Classification	Class II
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6 and yellow #5.
Product Quantity	100 products (Canada distribution only)
Recall Number	F-1705-2012

Product Description	MUFFINS PECAN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY 21-MAY-12 4.0oz
Code Info	UPC: 9564000029 All products distributed 5/10-17/2012.
Classification	Class I
Reason for Recall	The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared wheat (flour), milk, and soy (soybean oil and soy flour).
Product Quantity	126 products (Canada distribution only)
Recall Number	F-1706-2012

-

-