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U.S. Department of Health and Human Services

Enforcement Report - Week of December 30, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Bartlett Pasture Horse 10 Feed, Cleveland Carolina Champion Horse Feed, 50 lb bags, Manufactured by Bartlett Milling Co., Statesville, NC 28687 Lot 288 Class I Product may be contaminated with Rumensin. Bartlett Grain Company
Veterinary Cleveland Carolina Champion Horse Feed, 50 lb bags, Manufactured and Guaranteed by Eagle Roller Mill Co., Shelby, NC 28150. Lot 288 Class I Product may be contaminated with Rumensin. Bartlett Grain Company
Veterinary Pet Shoppe Chicken Jerky, in a 20 oz resealable plastic bag. Stored at room temperature. UPC Code: 049022575875 Lot # 13042301, Best By: 4/22/2015 Class III Presence of antibiotics (sulfaclozine) in product. Westminster Pet Products
Veterinary Purina Forage Balancer Block 3HL 33.3 lb. blocks; Formula No. 3117; Item No. 0030224; 90 units per pallet Lot No. 4MAR12LUB1 Class I Potential for an elevated urea level in some blocks. Land O Lakes Purina LLC
Devices Vancomycin Screen Agar catalog number 222204 Class II BD has confirmed reports that the affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. Also that the in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. Becton Dickinson & Co.
Devices Enterococcus Screen Agar QUAD Plate catalog number 222201 Class II BD has confirmed reports that the affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. Also that the in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. Becton Dickinson & Co.
Veterinary 711 Burkmann Feeds STRESS 700 MEDICATED PREMIX OR TOPDRESS FOR BEEF CATTLE, ***ACTIVE DRUG INGREDIENTS Chlortetracycline, Sulfamethazine**" Manufactured By BURKMANN FEEDS Danville, Kentucky 40422 NET WT. 25 LBS. (11.36 KG) 825 Batch #'s: 212104, 104095, 107215 Class II Unapproved indication of use for the drug combination of lasalocid and chlortetracycline. Specifically the statement and reduction of liver condemnations due to abscesses. Burkmann Industries Inc.
Veterinary 805 Burkmann Feeds Bovagard MEDICATED MIXING MINERAL FOR BEEF CATTLE, "***ACTIVE DRUG INGREDIENT Lasalocid.***" Manufactured By BURKMANN FEEDS Danville, Kentucky 40422 NET WT. 50 LBS. (22.67 KG) 825 Batch #'s:101215, 201295, 102185, 203245, 204135, 205015, 205285, 107075, 107165 & 108135. Class II Unapproved indication of use for the drug combination of lasalocid and chlortetracycline. Specifically the statement and reduction of liver condemnations due to abscesses. Burkmann Industries Inc.
Veterinary 812 Burkmann Feeds PASTURE BALANCER-RUM MEDICATED MIXING MINERAL FOR BEEF CATTLE, ACTIVE DRUG INGREDIENT Monensin***" Manufactured By BURKMANN FEEDS Danville, Kentucky 40422 NET WT. 50 LBS. (22.67 KG) 825 Batch #'s: 212134, 102115, 206045 & 108135. Class II Unapproved indication of use for the drug combination of lasalocid and chlortetracycline. Specifically the statement and reduction of liver condemnations due to abscesses. Burkmann Industries Inc.
Veterinary 814 Burkmann Feeds RUMAGARD MEDICATED MIXING MINERAL FOR BEEF CATTLE, "***ACTIVE DRUG INGREDIENT Monensin ***" Manufactured By BURKMANN FEEDS Danville, Kentucky 40422 NET WT. 50 LBS. (22.67 KG) 825 Batch #'s: 111204, 212154, 301095, 101215, 102105, 203195, 204135, 204165, 204575, 205135, 105295, 206125, 32206, 107145, 307285, 208215, 108275 Class II Unapproved indication of use for the drug combination of lasalocid and chlortetracycline. Specifically the statement and reduction of liver condemnations due to abscesses. Burkmann Industries Inc.
Veterinary 818 Burkmann Feeds RUMAMAG MEDICATED MIXING MINERAL FOR BEEF CATTLE, "***ACTIVE DRUG INGREDIENT Monensin.***" Manufactured By BURKMANN FEEDS Danville, Kentucky 40422 NET WT. 50 LBS. (22.67 KG) 825 Batch #'s: 201295, 103225 & 61316. Class II Unapproved indication of use for the drug combination of lasalocid and chlortetracycline. Specifically the statement and reduction of liver condemnations due to abscesses. Burkmann Industries Inc.
Veterinary 825 Burkmann Feeds I-MAX MEDICATED MIXING MINERAL FOR BEEF CATTLE, "***ACTIVE DRUG INGREDIENTS Lasalocid, Chlortetracycline***" Manufactured By BURKMANN FEEDS Danville, Kentucky 40422 NET WT. 50 LBS. (22.67 KG) 825 Batch #'s: 203075, 203245, 204035, 205285, 106105, 206305, 207085, 208075 Class II Unapproved indication of use for the drug combination of lasalocid and chlortetracycline. Specifically the statement and reduction of liver condemnations due to abscesses. Burkmann Industries Inc.
Veterinary 827 Burkmann Feeds COPRODUCT FORTIFIER-RUM MEDICATED MIXING MINERAL FOR BEEF CATTLE"***ACTIVE DRUG INGREDIENTS Monensin***" Manufactured By BURKMANN FEEDS Danville, Kentucky 40422 NET WT. 50 LBS. (22.67 KG) 825 Batch #'s: 101125, 203065, 203245, 204135, 205045 & 106295. Class II Unapproved indication of use for the drug combination of lasalocid and chlortetracycline. Specifically the statement and reduction of liver condemnations due to abscesses. Burkmann Industries Inc.
Veterinary 830 Burkmann Feeds RUMAX MINERAL MEDICATED MIXING MINERAL FOR BEEF CATTLE"***ACTIVE DRUG INGREDIENTS Monensin***" Manufactured By BURKMANN FEEDS Danville, Kentucky 40422 NET WT. 50 LBS. (22.67 KG) 825 Batch #'s: 30195, 1234, 103075, 103195, 204025,304275, 205045, 105145, 160165, 107015 & 108195. Class II Unapproved indication of use for the drug combination of lasalocid and chlortetracycline. Specifically the statement and reduction of liver condemnations due to abscesses. Burkmann Industries Inc.
Food Basma 3 Chris Court Dayton, New Jersey 08810 Tel.:7323559600 Fax: 7323559644 16 oz package This golden raisin product is labeled in a foreign language. no code on bag Class I Product contains undeclared sulfites. UNITED TRADING CENTER INC
Food TRC Golden Medium Raisins Packed by: The Raisin Company (PTY) LTD FActory AT: Noagspaal, Marchand, South Africa PO BOx 77, Marchand 8873 Produce of South Africa FBO CODE A6111 PO NUMBER P 95594-2 Class I Product contains undeclared sulfites. UNITED TRADING CENTER INC
Food Fat Bastard Gourmet Chick Dip Honey Roasted Hickory Smoke Sassy Barbecue, Net Wt. 12 Fl. Oz. (375 ml), UPC 8 91929 12702 8. The responsible firm name on the label is The Family Jewels, Montreal, MO 65591. No codes. Class II Product contains undeclared honey. The Family Jewels LLC
Food Salted Smoked Split Herring in bulk wooden boxes, Net Wt. 18 lbs., Product of Canada --- No label provided for bulk product. Code May 19 15 Class I The processed herring was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets. P East Trading Corporation
Drugs Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co, Deerfield, IL (NDC 0363-0495-66); Being Well brand distributed by Save-A-Lot Food Stores, Ltd, Earth City, MO (NDC 46994-458-66); CareOne brand distributed by FoodHold, USA LLC, Landover, MD (NDC 41520-458-66); Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 UPC: 041190223343); Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 UPC: 370030677689); Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 UPC: 015400121026) Batches: Exp 05/16: 4GE1457; 4GE1500; 4GE1819; 4GE1893; 4HE1255; 4HE1396; 4HE1620; 4HE1656; 4HE1811; 4JE1035; 4JE1212; 4JE1324; 4JE1513; and 4KE1377 Class III Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester Perrigo Company PLC
Drugs HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741 Lot #: V0814H, V0814J, Exp 08/2016; V1014L, Exp 11/2016; V1114A, Exp 11/2016; V0115G, V0115H, Exp 01/2017; V0215A, V0215B, Exp 02/2017; V0315G, V0315H, V0315O, Exp 03/2017; V0515C, V0515D, Exp 05/2017. Class III Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Oasis Medical, Inc.
Drugs HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741 Lot #: V1014M, Exp 10/2016; V1214B, Exp 12/2016; V0415H, Exp 4/2017. Class III Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Oasis Medical, Inc.
Drugs HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741 Lot #: V0814C, V0814D, Exp 8/2016; V1014A, V1014B, Exp 10/2016; V1214C, Exp 12/2016; V0115A, V0115B, Exp 01/2017; V0215C, Exp 02/2017; V0315C, V0315D, Exp 03/2017; V0515A, V0515B, Exp 05/2017. Class III Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Oasis Medical, Inc.
Biologics Blood and Blood Products for Reprocessing W202214162485 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross, Penn Jersey Region
Devices Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. 15086733 15086937 15095168 15095332 15095772 15096137 15096516 15086756 15095022 15095212 15095333 15095773 15096183 15096627 15086832 15095045 15095213 15095334 15095842 15096184 15096628 15086833 15095088 15095214 15095347 15095843 15096222 15096629 15086864 15095103 15095254 15095490 15095844 15096291 15096703 15086865 15095128 15095255 15095504 15095936 15096292 15096704 15086910 15095136 15095274 15095505 15096020 15096412 15096722 15086911 15095137 15095275 15095561 15096021 15096413 15096723 15086912 15095166  ...
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Class II CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion. CareFusion 303, Inc.
Devices DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker. SN: 73962222, 73962223, 73962224, 73962225, and 73962226 Class III Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms. BC Group International Inc
Devices Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). 9905776 9905792 12331254 12350410 12352410 12364342 12364343 12364901 12369088 12401328 12402583 12479923 12481239 12593721 12623833 12623957 12668253 12679872 12697242 12698542 12736367 12805782 12807757 12868325 12870021 12916518 12918611 12919079 12921157 13034011 13034375 13038124 13050300 13050648 13051034 13061112 13072829 13075412 13077962 13088823 13106029 13106030 13106138 13106140 13122164 13122401 13122402 13122936 13136786 13141565 13142603 13143660 13143809 13143889 13167255 13169672 13173261 13177210 13178248 13178389 13178391 13178512 13178968 13178969 13186760 13187737 13188106 13189792 13190670 13216601 13220274 13316434 13316444 13316453 13316473 13316496 13317481 13317552 13317553 13457448 13463929 13464899 13469917 13470004 13470021 13476713 13476912 13477643 13480785 13482441 13482518 13489475 13491251 13521218 13559325 13559686 13569291 13582129 13602388 13621652 13621847 13622337 13624519 13628251 13628876 13628877 13628918 13629153 13658756 13732201 13744088 13781347 13782359 13796475 13809762 13813539 13818275 13853185 13853375 13858182 13858798 13858976 13862567 13867168 13895850 13895989 13896107 13896108 13896110 13896347 13896456 13896669 13896747 13896748 13910604 13922145 13951711 13994625 13995332 14000190 14006401 14035430 14036040 14084571 14084629 14126982 14126990 14151686 14152555 14172846 14190913 14228679 14235981 14253982 14258801 14259542 14280651 Class II CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could lead to an incorrect measurement of CO2. CareFusion 303, Inc.
Devices Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. All Lots Class II The flexible shaft of the instruments may break during orthopedic spinal surgery. To date there have been 18 reports of breakages during surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient. Aesculap, Inc.
Devices Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. all lots Class II The flexible shaft of the instruments may break during orthopedic spinal surgery. To date there have been 18 reports of breakages during surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient. Aesculap, Inc.
Devices Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. All Lots Class II The flexible shaft of the instruments may break during orthopedic spinal surgery. To date there have been 18 reports of breakages during surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient. Aesculap, Inc.
Devices Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037. All Lots Class II The flexible shaft of the instruments may break during orthopedic spinal surgery. To date there have been 18 reports of breakages during surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient. Aesculap, Inc.
Devices 1 Step 12 Panel Cup, Item No. NBCA-12M-W 143107 151657 153155 153529 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices 10-Panel Pipette Drug Screen, Item No. PSP-10M 153135 154119 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA 153632 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA 144376 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5. 151688 152423 153307 153912 153921 153961 153962 154104 154112 154236 154264 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP G140255-C G140422-C G150063-C G150184-C G150211-C G150226-C G150240-C G150286-C Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices BZO Strip Dip Card (300ng/ml)*, Item No. 100170 141233 141669 141790 141820 141958 142082 142531 142532 142835 143020 143471 143553 152021 152432 152546 153094 153538 152104 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5 142709 142840 143008 143571 143665 144217 152234 152379 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 143235 144216 151591 153132 153489 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D 143978 144485 151982 153095 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices DrugSmart 11 Test Cup, Item No. 61127D 144196 144375 150096 151980 152737 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D 152736 143864 150204 151981 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices DrugSmart 9 Test Cup (BUP), Item No. 60960D 144029 152738 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D 143516 143977 150397 152070 152751 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D 150309 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D 142122 142699 143170 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D 142141 143169 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices EDI BZO Uncut Sheet - Cup*, Item No. 160170 141260 141294 141909 141925 142074 142243 142428 142614 142712 142911 144555 151925 152003 152223 152498 152723 152897 153311 153559 153818 154184 152103 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142 143037 143106 144152 144218 152456 152457 152698 153048 153129 153201 153385 153648 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131 152459 152823 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023 143345 143442 151537 152163 152334 152674 152697 153075 153127 153216 153390 153499 153634 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013 141900 142194 142959 144377 151998 152740 152993 153229 153363 153544 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016 141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5 143846 144380 150312 150505 153177 153488 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP 144103 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W 141758 141921 142657 143178 143581 144563 151337 152240 152782 153154 153401 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP 143847 144565 150313 152169 152338 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3 144009 144078 144099 144125 144193 144268 152996 153077 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P 143861 144204 144263 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W 143937 144574 145061 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU G140256 G140281 G140307 G140340 G140418 G140419 G150135 G150141 G150187 G150257 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX 152164 153134 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 10 Panel Cup, Item No. PSCup-10M 142596 142984 142985 143144 143145 143146 143240 143241 143351 143875 144102 144106 144239 144241 150651 151706 152165 152167 152168 153102 153107 153251 153411 153412 153633 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM 144240 150059 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300 141963 142196 143166 143475 143827 152038 152172 152218 152323 152393 152394 152870 153362 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU. 144902 150474 151686 151687 152043 152225 152312 152402 152952 153306 153563 153663 153664 153665 153680 153682 153703 153704 153759 153760 153763 153852 153853 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU 142986 143352 151745 152170 153262 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M 142570 144104 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 12 Panel Dip Card, Item No. PSD-12BUP 152401 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 5 Panel Dip Card, Item No. PSD-12BUP 141953 151770 151771 153522 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300 152912 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU G150179 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU G140258 G140313 G140314 G140368 G140384 G140389 G140399 G140426 G150185 G150199 G150246 G150307 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB, 141955 142043 142055 142161 142513 142600 142824 142937 142938 142969 143143 143149 143234 143513 143758 143806 143807 144441 152035 152042 152075 152911 153237 153240 153523 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU G150001 G150244 G150293 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3 152112 152705 153400 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M 142059 143006 143570 152175 153524 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 8 Panel Dip Card, Item No. PSD-8P 152305 152306 153503 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300 152950 152951 153325 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300 152950 152951 153325 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300 G150252 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W 141906 143153 143803 150003 150207 150650 151786 152081 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W 141779 142656 142963 143874 144562 151996 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W 142964 150790 151707 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W 152171 152216 153103 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W 142153 142594 143825 144227 152005 152972 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA 153709 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU G150189 G150271 G150299 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU G150328 Class III Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Ameditech Inc
Devices Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System. LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134 Class II Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length DePuy Spine, Inc.
Biologics Source Plasma 15JCTT1969 Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Plasma Biological Services Inc
Biologics Source Plasma 15JCTT3798; 15JCTT5070 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed Plasma Biological Services Inc
Biologics Red Blood Cells, Leukocytes Reduced W1170150316507 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Plasma Frozen within 24 hours (FP24) W1170150316507 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Apheresis Platelets, Leukocytes Reduced W158015801730-part 1; W158015801730-part 2 Class III Platelets, with insufficient plasma volume to support the platelet yield, were distributed. ARUP Laboratories, Inc.
Devices Cardinal Health Tiny Toes; 11470-010T Infant heel warmer All product in distribution Class II Heel warmers may cause first and second degree burns. Philips Electronics North America Corporation
Devices Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A  1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate. All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector. Class II Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector. MOOG Medical Devices Group
Devices Mobile X-ray system MobileDaRt Evolution/FDR Go Software Serial No. 41DBBB534001 41DBBB534004 41DBBB534002 41DBBB534005 41DBBB534006 41DBBB536001 41DBBB536007 41DBBB536008 41DBBB536009 41DBBB536010 41DBBB539001 41DBBB539002 41DBBB539003 41DBBB539004 41DBBB53A001 M1DBBB547001 M1DBBB547002 M1DBBB547003 M1DBBB547004 M1DBBB547005 M1DBBB547006 M1DBBB547007 M1DBBB548001 M1DBBB548002 41DBBA136010 41DBBA136014 41DBBA145008 41DBBA145009 41DBBA145016 41DBBA141006 41DBBA147004 41DBBA149021 41DBBA149022 41DBBA132003 41DBBA142001 41DBBA14A004 41DBBA132001 41DBBA132010 41DBBA141012 41DBBA142012 41DBBA147017 41DBBA147028 41DBBA146015 41DBBA146017 41DBBA142004 41DBBA142014 41DBBA148002 41DBBA131018  ...
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Class II Shimadzu Corporation is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly. Shimadzu Medical Systems
Devices Brilliance 64 Computed Tomography X-ray system Model No. 728231; S/N: 4001, 9074, 9099, 9538, 9549, 9573, 9638, 9646, 9656, 9667, 9703, 9738, 9755, 9782, 9811, 9822, 9909, 9923, 9927, 9933, 10021, 10042, 10077, 10150, 10180, 10379, 29056, 29107, 29115, 90124, 90154, 95024, 95130, 95222, 95236, 95258, 95261, 95364, 95399, 95410, 95475, 95551, 95614, 95668, 95688 &  ...
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Class II Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2. Philips Medical Systems (Cleveland) Inc
Devices Brilliance iCT Computed Tomography X-ray system Model No. 728306; S/N: 85015, 85021, 85028, 85034, 85036, 85039, 85042, 85047, 85051, 100030, 100038, 100040, 100051, 100054, 100058, 100065, 100072, 100093, 100094, 100099, 100101, 100140, 100144, 100162, 100181, 100190, 100214, 100217, 100228, 100236, 100244, 100278, 100421, 100462, 100472, 100613, 100616, 100624, 100627, 100628, 100632, 100639, 100640, 100641, 100644, 100647,  ...
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Class II Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2. Philips Medical Systems (Cleveland) Inc
Devices Brilliance iCT SP Computed Tomography X-ray system Model No. 728311; S/N: 200047, 200051, 200067, 200074, 200098, 200127, 200200, 200202, 200203, 200204, 200206 & 200209. Class II Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2. Philips Medical Systems (Cleveland) Inc
Devices Ingenuity Core Computed Tomography X-ray system Model No. 728321; S/N: 52007, 52008, 52010, 52013, 52014, 52015, 52018, 52019, 52020, 52021, 52024, 52027, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52040, 52041, 52042, 52045, 52046, 52047, 52048, 52051, 52053, 52055, 52057, 52058, 52060, 52064, 52065, 52067, 52068, 52069, 52070, 52075, 52078, 310017, 310026, 310039, 310042, 310052, 310055,  ...
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Class II Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2. Philips Medical Systems (Cleveland) Inc
Devices Ingenuity Core 128 Computed Tomography X-ray system Model No. 728323; S/N: 30016, 32012, 32013, 32016, 32024, 32028, 32033, 32036, 32041, 32046, 32048, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32058, 32059, 32062, 32063, 32064, 32068, 32069, 32070, 32072, 32073, 32074, 32075, 32077, 32078, 32079, 32081, 32082, 32083, 32084, 32086, 32087, 32089, 32092, 32093, 32095, 32097, 32098, 32099,  ...
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Class II Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2. Philips Medical Systems (Cleveland) Inc
Devices Ingenuity CT Computed Tomography X-ray system Model No. 728326; S/N: 2, 1234, 30005, 30009, 30017, 30018, 30020, 30023, 30028, 30031, 30034, 30037, 31001, 32065, 32067, 52030, 52031, 52044, 52049, 52050, 300159, 300204, 300205, 300207, 300208, 300209, 310002, 310003, 333057, 333064 & 336061. Class II Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2. Philips Medical Systems (Cleveland) Inc
Devices MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix. Lot numbers: 120416D 120521E 120606F 120613B 120621A 120910A 120926H 121005C 121022A 121031A 121119B 121217F 130131A 130207A 130213A 130220H 130227C 130307B 130320A 130328A 130426A 130508A 130516A 130619B 130613H 130716C 130815E 130822C 130911C 131003E 131113C 131125D 131212F 140109F 140115D 140127B 140204B 140226J 140304A 140310K 140317B 140325B 140430C 140507B 140604C 140610E 140617H 140624E 140707G 140710D 140715H 140804D 140819B 140828C 140916E 140922C 140926C 141008E 141016E 141103A 141106A 150415D 150625B 150813B 151006G Class II Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE 30 Stapler was associated with incomplete firing of staples, potentially resulting in an incomplete transection or anastomosis of tissue during the surgical procedure. Cardica, Inc.
Devices MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. The staple line length is 30 mm long. The Stapler can be loaded, fired, and reloaded with the MicroCutter XCHANGE 30 Cartridge for up to the number deployments indicated on package label in a single surgical procedure. The Stapler can fire different sized staples, with the size of the staple indicated by the color of the MicroCutter XCHANGE Cartridges. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix. Lot numbers: 150309A 150527D 150603F 150617B 150820A 150902A 150909B 150924A. Class II Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE 30 Stapler was associated with incomplete firing of staples, potentially resulting in an incomplete transection or anastomosis of tissue during the surgical procedure. Cardica, Inc.
Devices Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland Model # 01-8507-400-00 & Model # 89-8507-400-00 Class II The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. Zimmer, Inc.
Devices Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland Model # 01-8507-400-10 & Model # 89-8507-400-10 Class II The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. Zimmer, Inc.
Biologics Source Plasma 4560213240 Class II Blood product, collected from a donor who received a tattoo within 12 months of donating, was distributed. Octapharma Plasma, Inc.
Biologics Apheresis Platelets, Leukocytes Reduced W398515063109T (triple collection) Class II Apheresis products, in which the platelet yield was below 3.0x10^11, were distributed. Community Blood Center of Carolinas
Devices Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001). SN 000242 SN 000244 SN 000246 SN 000247 Class II An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization. Arthrosurface, Inc.
Devices BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer® tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer® Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions. Catalog (Ref) # 367856; Lot Number 5014806 Class II Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying. Becton Dickinson & Company
Devices Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 Guiding Sheath 6F, 45 cm, ST, TB H74939277645120 Guiding Sheath 6F, 45 cm, MP, CC H74939277645210 Guiding Sheath 6F, 45 cm, MP, TB H74939277645220 Guiding Sheath 6F, 65 cm, ST, CC H74939277665110 Guiding Sheath 6F, 65 cm, ST, TB H74939277665120 Guiding Sheath 6F, 90 cm, ST, CC H74939277690110 Guiding Sheath 6F, 90 cm, ST, TB H74939277690120 Guiding Sheath 6F, 90 cm, MP, CC H74939277690210 Guiding Sheath 6F, 90 cm, MP, TB H74939277690220 Guiding Sheath 7F, 45 cm, ST, CC H74939277745110 Guiding Sheath 7F, 45 cm, ST, TB H74939277745120 Guiding Sheath 7F, 45 cm, MP, CC H74939277745210 Guiding Sheath 7F, 45 cm, MP, TB H74939277745220 Guiding Sheath 7F, 65 cm, ST, CC H74939277765110 Guiding Sheath 7F, 65 cm, ST, TB H74939277765120 Guiding Sheath 7F, 90 cm, ST, CC H74939277790110 Guiding Sheath 7F, 90 cm, ST, TB H74939277790120 Guiding Sheath 7F, 90 cm, MP, CC H74939277790210 Guiding Sheath 7F, 90 cm, MP, TB H74939277790220 Guiding Sheath 8F, 45 cm, ST, CC H74939277845110 Guiding Sheath 8F, 45 cm, ST, TB H74939277845120 Guiding Sheath 8F, 45 cm, MP, CC H74939277845210 Guiding Sheath 8F, 65 cm, ST, CC H74939277865110 Guiding Sheath 8F, 65 cm, ST, TB H74939277865120 Guiding Sheath 8F, 90 cm, ST, CC H74939277890110 Guiding Sheath 8F, 90 cm, ST, TB H74939277890120 Product Usage: The Chariot Guiding Sheath is designed to perform as an introducer sheath for delivering interventional and diagnostic devices into the peripheral vasculature. The guiding sheath has a coiled shaft design and comes with a straight or preformed multipurpose tip shape. It is equipped with a cross-cut hemostatic valve or Tuohy-Borst adapter to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast medium. It is packaged with a dilator to facilitate delivery over a guidewire. The guiding sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The outer surface of the guiding sheath has a hydrophilic coating from the distal tip to approximately 9 cm from the hub. The distal tip has a radiopaque marker band approximately 6 mm from the distal edge, to help with guiding sheath placement. Batch 17797683 17797684 17797685 17797686 17797687 17797688 17797689 17797690 17797691 17797692 17797693 17797694 17797695 17797696 17797697 17798268 17798269 17798270 17798271 17798272 17798273 17806530 17829972 17829976 17830219 17839346 17839347 17839350 17866538 17866881 17866882 17872044 17872045 17915368 17915369 17940916 17941111 17943786 17945064 17945224 17946351 17949277 17950404 17951572 17952749 17953534 17958093 17958489 17961473  ...
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Class I Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft separation. The most severe outcome of this failure is embolism of device fragments. Boston Scientific Corporation
Devices VAPR® TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) U1509202 and U1509162 Class II Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic, drug refractory atrial fibrillation. Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Lot numbers: 16743760, 17135083, 17614450, 18140623, 18162387. Expiration Date Range: 2/16/2017 to 7/3/2018. Class II During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentation. Boston Scientific Corp
Devices IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation. Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Lot numbers: 16743398, 17135082.. Expiration Date Range: 2/16/2017 to 7/22/2017 Class II During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk documentation. Boston Scientific Corp
Devices IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation. Material Number: M004PM4500N40; Catalog number: PM4500N4; Lot numbers: 16309584, 16615976, 16623754, 16623755, 16722434, 16736927, 16739588, 16743271, 16872124, 16999075, 17118111, 17157418, 17201805, 17222051, 17222052, 17370483, 17376573, 17376574, 17436562, 17436563, 17436565, 17451802, 17478950, 17499145, 17499152, 17590503, 17611785, 17625992, 17768306, 17791420, 17925492, 17925493, 18012208, 18161715. Expiration Date Range:8/15/2016 to 7/2/2018. Class II During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk documentation. Boston Scientific Corp
Devices IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic, drug refractory atrial fibrillation. Material Number: M004PM4790N40; Catalog number: PM4790N4; Lot numbers: 16743269, 16818653, 16818654, 16872007, 16993525, 17511087, 18159904, 18385792. Expiration Date Range: 9/1/2016 to 9/20/2018. . Class II During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentation. Boston Scientific Corp
Devices Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol Lot-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016 Class II Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components. Rainbow Specialty & Health Products
Devices Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil Lot - 5012, Exp-102016 Class II Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components. Rainbow Specialty & Health Products
Devices Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty. lot #62460264 Class II Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264 Zimmer Manufacturing B.V.
Devices Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension® clinical chemistry system. The RMS doubles the available storage of refrigerated Flex® reagent cartridges on the Dimension® system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex® reagent cartridges, allowing the Dimension® system to process samples without interruption. Dimension EXL with LM Catalog Numbers 778021.911 (Domestic)/ 778021.931 (Intl). All serial numbers. Class II Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container. Siemens Healthcare Diagnostics Inc.
Devices Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension® clinical chemistry system. The RMS doubles the available storage of refrigerated Flex® reagent cartridges on the Dimension® system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex® reagent cartridges, allowing the Dimension® system to process samples without interruption. Dimension EXL with LM STM Catalog Numbers 778031.911 (Domestic) /778031.931 (Intl). All serial numbers. Class II Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container. Siemens Healthcare Diagnostics Inc.
Devices Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension® clinical chemistry system. The RMS doubles the available storage of refrigerated Flex® reagent cartridges on the Dimension® system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex® reagent cartridges, allowing the Dimension® system to process samples without interruption. Dimension RxL Max w/o HM Catalog Numbers 752000.901 (Domestic)/752000.921 (Intl). RxL Max HM Catalog Numbers 752000.911 (Domestic)/752000.931 (Intl). All serial numbers. Class II Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container. Siemens Healthcare Diagnostics Inc.
Devices Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension® clinical chemistry system. The RMS doubles the available storage of refrigerated Flex® reagent cartridges on the Dimension® system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex® reagent cartridges, allowing the Dimension® system to process samples without interruption. Dimension RXL MAX HM STM (D140066). Class II Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container. Siemens Healthcare Diagnostics Inc.
Devices A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones. Part number and size (non-sterile) 816140010, 4.0X10MM; 816140012, 4.0X12MM; 816140014, 4.0X14MM; 816140016, 4.0X16MM; 816140018, 4.0X18MM; 816140020, 4.0X20MM; 816140022, 4.0X22MM; 816140024, 4.0X24MM; 816140026, 4.0X26MM; 816140028, 4.0X28MM; 816140030, 4.0X30MM; 816140032, 4.0X32MM; 816140034, 4.0X34MM; 816140036, 4.0X36MM; 816140038, 4.0X38MM; 816140040, 4.0X40MM; 816140042, 4.0X42MM; 816140044, 4.0X44MM; 816140046, 4.0X46MM; 816140048, 4.0X48MM; 816140050, 4.0X50MM; 816140055, 4.0X55MM; 816140060,  ...
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Class II These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the screw does not lock into the plate and backs out, a revision surgery may be necessary. Biomet, Inc.
Devices Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures. Model numbers 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, 10848355. Serial Numbers 123026, 147909, 123031, 103030, 147912, 147910, 147921, 147919, 131005, 121096, 125004, 137551, 121088, 109104, 109105, 109107, and 121085. Class II Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening. Siemens Medical Solutions USA, Inc
Devices Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified. 00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012 Class II Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification. Synaptive Medical, Inc.
Devices Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System. Lot number MDHZ620 Class II The sterile blade will not fit into the handle provided with the ETTD system. Instratek, Incorporated
Devices Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency Lot Number 44637, exp. 2016-11-30 Class II Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. This could lead, under certain circumstances, to an erroneously increased result with a Factor VIII Chromogenic Assay. Siemens Healthcare Diagnostics, Inc.
Devices Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients. Catalog numbers: 8416400/8417400 distributed June 2011 – October 2015. Class I The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority. Draeger Medical, Inc.
Devices Etest® Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest® is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. Ref. 4122434, Lot numbers: 1004331500, 1004271120, 1004178060, 1003977300, 1003697470, 1003415090, 1003276060, 1003069230, 1002488490 and 1001936360. Class I Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. Biomerieux
Devices Etest® PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest® is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. Ref. 4122434, Lot numbers: 1004331500, 1004271120, 1004178060, 1003977300, 1003697470, 1003415090, 1003276060, 1003069230, 1002488490 and 1001936360. Class I Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. Biomerieux
Devices Etest® PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest® is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. Ref. 521418, Lot numbers: 1004398470, 1004276460, 1004180840, 1003980200, 1003699550, 1003416920, 1003105180, 1002995820, 1002482640, 1002375410, 1002276210 and 1002092270. Class I Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. Biomerieux
Devices Etest® PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest® is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. Ref. 521458, Lot numbers: 1004397280, 1004271100, 1003977350, 1003903650, 1003561810, 1003239850, 1002489700, 1002273480, 1002216620 and 1002120370. Class I Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. Biomerieux
Food Winn Dixie Old Fashioned Potato Salad, Net Wt. 16oz (1 LB) 454g. Use By Dec 08 15 30, UPC Code: 021140021755 Class II Possible Listeria monocytogenes contamination. Reser's Fine Foods Inc.
Devices FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens. Cat. no. K31 Lot no.15231 Class II The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination. Hardy Diagnostics
Biologics Apheresis Platelets, Leukocytes Reduced W398515063035X (triple collection) Class II Apheresis products, in which platelet yield did not meet specifications, were distributed. Community Blood Center of Carolinas
Biologics Apheresis Platelets, Leukocytes Reduced W043215091070 (double collection) Class III Apheresis products, for which quality control testing for residual white blood cell count was not performed, were distributed. Blood Assurance Inc
Biologics Apheresis Red Blood Cells, Leukocytes Reduced W066515425671 Class III Apheresis products, stored at the incorrect temperature, were distributed. Blood Bank of Alaska, Inc.
Biologics Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated W066515425702 Class III Apheresis products, stored at the incorrect temperature, were distributed. Blood Bank of Alaska, Inc.
Biologics Apheresis Platelets, Leukocytes Reduced W04071518530 (double collection) Class II Apheresis products, in which viral testing sample was exposed to unacceptable temperatures during storage, were distributed. Indiana Blood Center
Biologics Red Blood Cells, Leukocytes Reduced W201115472773 Class III Blood product, for which a unit received inadequate additive solution, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells, Leukocytes Reduced W087615030965; W087615031793 Class III Blood products, collected from a therapeutic donor with polycythemia and hemochromatosis, were distributed. Virginia Blood Services
Devices Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures Synvasive Part number: 11-4770; Part number: 19075127YT1; Lot numbers: 45104 and 43054. Class II Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm. Synvasive Technology Inc
Devices Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35. Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004. Class II Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield). Terumo Medical Corp
Devices Black Mamba Suture Passer Catalog Number: 110010849 Lot Number Identification: 167880, 169620, 253190, 520810, 538490, 551550, 716270, 960180 Class II There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to not actuate properly. 6 complaints have been received in which 3 have been reported with a delay up to 10 minutes. Biomet, Inc.
Devices Green Mamba Suture Passer Catalog Number: 110010850 Lot Number Identification: 167890, 231120, 253210, 550050, 551580, 716300, 953230 Class II There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to not actuate properly. 6 complaints have been received in which 3 have been reported with a delay up to 10 minutes. Biomet, Inc.
Devices Syngo Imaging XS is a Picture Archiving and Communication System (PACS) Model number 10558586 Software version VB10C Class II For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo Imaging XS printer configuration file. Siemens Medical Solutions USA, Inc
Devices Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700. Reference #WP-7700; Lot 8605A Class II Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an isolated incident or if the whole lot is impacted. Airways Development LLC
Devices MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). all units distributed since 1991 Class II Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others. Siemens Medical Solutions USA, Inc
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