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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories. Software versions 1.0, 1.01, 1.1.1, 1.1.2 Class II The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. This resulted in the database files meeting its maximum capacity and causing system performance issues. Sysmex America, Inc.
Devices MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702. Lot Numbers: D100891, D101191, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521, D122361, D81701, D83031, D90231, D90911, D91171, D91821, D92081, D92301, D92601, D92801, D93411, DA82321, DA82451, and DA90891 Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Ecolab Inc
Devices MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Lot Numbers: D100131, D100341, D101521, D101861, D101871, D101881, D101891, D101901, D101931, D101941, D101951, D102491, D102531, D102651, D102731, D110691, D110831, D110841, D111021, D111111, D111221, D111381, D111451, D111651, D111801, D111961, D112091, D112231, D112371, D112511, D112661, D112791, D112911, D113061, D113211, D113341, D113481, D120111, D120261, D120401, D120551, D120661, D120811, D120811A, D120941, D121091, D121311, D121371,  ...
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Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Ecolab Inc
Devices MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Lot Numbers: 126429V, 126602V, 126611V, 126612V, 126613V, 126614V, 127176V, 127182V, 127331V, 127382V, 137533V, 137826V, 137967V, 137666V, 137787V, and 137817V Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Ecolab Inc
Devices MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Lot Numbers: D102471, D102661, D102701, D110831, D111101, D111151, D111231, D111441, D112301, D112851, D112991, D113551, D120821, D121181, D121951, D122421, D130171, D130381, D82321, D82871, D83261, D90261, D91671, DA102491, DA90491, DA90621, DA91061, and DA91671 Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Ecolab Inc
Devices MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Lot Numbers: D101931, D101981, D102471, D110561, D111801, D112301, D112511, D112991, D113421, D120191, D120651, D121521, D122221, D123401, D130171, D130311, D130431, D82061, D82321, D82871, D83371, DA101891, DA81561, DA82061, and DA85161 Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Ecolab Inc
Devices Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois Lot Numbers: D111571, D120421, D123471, D83111, DA90721, and DA90961 Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Ecolab Inc
Devices 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover Microtek/Ecolab Lot Nos. D91821, D92081, D92301, D93411, D100891, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521 - Custom Medical Lot Nos. 15831-0906,  ...
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Class II No endotoxin (LAL) testing to proper level. Custom Medical Specialties, Inc.
Food Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle). lot J53Q Class II Mira Health Products Ltd. recalled products marked as Dietary Supplements due to the use of DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract in their raw materials. Mira Health Products Ltd.
Devices enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods. Autoverification and Custom Rules for enGen Laboratory Automation Systems using enGenTM Select v5.0 Class II Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems. Ortho-Clinical Diagnostics
Devices enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods. Custom v3.2.2 & Below Configuration Files Class II Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides. 1) VITROS 250 (Product Code 8132086; Model # 3332); 2) VITROS 350 (Product Code 6802153; Model # 3330); 3) Mixing Cup Arrays (Product Code 1631779; Model # n/a) Class II Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays. Ortho-Clinical Diagnostics
Devices D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography. Catalog number: 220-0201: Reorder Pack Lot No./Expiration date: 20030322 3/31/2014 20030337 3/31/2014 64000081 5/31/2014 64000331 5/31/2014 64000332 5/31/2014 64000888 08/31/2014 64001344 04/30/2014 64002239 11/30/2014 ( 64002240 08/3112014 64002241 11/30/2014 Class III D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System. Bio-Rad Laboratories, Inc.
Devices Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1 Class II The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process. Neuro Kinetics, Inc.
Devices BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy. Model/Catalog Code: 55830-25A Instrument Star Unit ML; Serial Numbers (US Devices): 1205112007, 1205112010, 1205112011, 1205112013, 1205112014, 1205112019, 1205112021, 1205112029, 1205112034, 1205112045; Serial Numbers (Non-US Devices): 1205112004, 1205112006, 1205112008, 1205112009, 1205112015, 1205112016, 1205112017, 1205112018, 1205112020, 1205112023, 1205112025, 1205112026, 1205112027, 1205112030, 1205112032 Class II Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirectly, enter the patient's body, potentially leading to infection and serious injury. Brainlab AG
Devices Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring. ADVIA 1200 V2.00 - 10386841 ADVIA 1200 V2.01 - 10469445 ADVIA 1650 V3.52 - 10318424 ADVIA 1650 V4.01 - 10285281 ADVIA 1800 V2.01 - 10639244 ADVIA 2400 V4.01 - 10639265 Class II The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC). Siemens Healthcare Diagnostics, Inc.
Biologics AllSet+" Gold HLA-A Low Res SSP, 54310D; UniTray® A Locus SSP, 7860010; UniTray® A Locus SSP w/ Taq, 7860110; AllSet+" Gold HLA-ABC Low Res SSP, 54340D; UniTray® ABC SSP, 7800010; UniTray® ABC SSP w/ Taq, 7800110; AllSet+" Gold HLA-AB/DR Low Res SSP, 54350D; UniTray® AB/DR SSP, 810010; UniTray® AB/DR SSP w/ Taq, 7810110; AllSet+" Gold HLA-AB/DR/DQ Low Res SSP, 54360D; UniTray® AB/DR/DQ SSP, 7850010; UniTray® AB/DR/DQ SSP w/ Taq 7850110. 54310D - 0221256853, 0221385981; 860010 - 0221221256, 0221256848; 7860110  ...
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Class II HLA typing assay, associated with false negative results, were distributed. Life Technologies Corporation
Biologics Platelets Pooled Leukocytes Reduced W036811822421 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W036811257824 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036811257824 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Invitrogen by Life Technologies: 54350D ALLSET GOLD HLA ABDR LOW RES, 54360D ALLSET GOLD HLA ABDRDQ LOW RES, 54370D ALLSET GOLD HLA DR LOW RES SSP, 54380D ALLSET GOLD HLA DRDQ LOW RES,7810010 AB/DR SSP UNITRAY 10 TESTS, 7810110 AB/DR SSP UNITRAY W/TAQ 10 TS, 7820010 DR 4T SSP UNITRAY 40 TESTS,7840010 DR/DQ 2T SSP UNITRAY 20 TESTS,7840110 DR/DQ 2T SSP UNITRAY W/TAQ 20T. 7850010 AB/DR/DQ SSP UNITRAY 10 TESTS 7850110 AB/DR/DQ SSP UNITRAY W/TAQ 10T 54350D: 0361255129, 0361304515, 0361357615 54360D: 0291247232, 0291293558, 0291306794 54370D: 0201205205, 0201303555 54380D: 0301216651, 0301272183, 0311312025, 0311377599 7810010: 0361316325 7810110: 0361316325, 1409712 7820010: 0201216655 7840010: 0301221267, 0311344994 7840110: 03012212671344796, 03012212671346090, 03012212671346863, 03012212671350644, 03012212671352619, 03012212671375757, 03012212671391605, 03012212671393093, 03012212671396221, 03012212671405133, 03012212671417015, 03012212671420379, 03012212671427118, 03012212671429556, 03012212671438257, 03113449941451386, 03113449941452442, 7850010: 0291255127 7850110: 02912551271345427, 02912551271360761, 02912551271378014, 02912551271393696, 02912551271419162, 02912551271427119, 02912551271439780 Class II HLA typing assay, associated with false negative results, were distributed. Life Technologies Corporation
Biologics Red Blood Cells Leukocytes Reduced W038113228719 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W201213801270 Class II Blood product, which did not meet the acceptable product specifications, was distributed. American National Red Cross (the)
Biologics Cryoprecipitated AHF, Pooled W068512003196; W068511023243; W068510015032 Class II Blood products, collected from a donor with a history of Hepatitis after age 11, were distributed. Inland Northwest Blood Center
Biologics Plasma Frozen W068511360535; W068511010284; W068510013295 Class II Blood products, collected from a donor with a history of Hepatitis after age 11, were distributed. Inland Northwest Blood Center
Biologics Cryoprecipitated AHF 0902184 Class II Blood products, collected from a donor with a history of Hepatitis after age 11, were distributed. Inland Northwest Blood Center
Biologics Red Blood Cells Leukocytes Reduced W068512381698; W068512003196; W068511023243; W068511360535; W068511010284; W068510017272; W068510015032; W068510013295; W068510011204; 0902184 Class II Blood products, collected from a donor with a history of Hepatitis after age 11, were distributed. Inland Northwest Blood Center
Biologics Invitrogen by Life Technologies: DRB1-15 SSP UniTray® Kit, 450102D; DRB1-15 SSP UniTray® Kit with Taq Polymerase, 450112D; AllSet+" Gold SSP HLA DRB1-15/16 High Res Kit, 54290D. 450102D: 010743202, 0111049955, 0111274159, 011872999 450112D 010743202807163, 010743202824730, 010743202847129, 010743202867121, 010743202904081, 01110499551314672, 01110499551273533, 01112741591345434, 01112741591377037, 011872999934454, 011872999943913, 011872999952219, 0118729991029899 54290D: 001769069, 001796673, 0021103796, 0021216660, 0021344999, 002905389, 002979632 Class II HLA typing assay, associated with false negative results, were distributed. Life Technologies Corporation
Biologics Source Plasma 04205157078; 04205179947; 04205172243 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Csl Plasma, Inc.
Biologics Red Blood Cells Deglycerolized Leukocytes Reduced W117012114683 Class III Blood product, failed to meet the minimum specification for percent red blood cell recovery, was distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells Leukocytes Reduced W089812403071 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Fresh Frozen Plasma W089812403071 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Red Blood Cells Leukocytes Reduced W140913280879 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. South Texas Blood & Tissue Center
Veterinary OroCAM is supplied in three glass vial sizes containing 6 mL, 11 mL and 33 mL of meloxicam. Each vial has a different metered dose pump delivering a dose of 0.25 mg, 0.50 mg, or 1.075 mg, per spray, respectively. Manufactured for Abbott Laboratories; North Chicago, IL 60064 USA; Product of Spain *** US PRODUCTS *** 1) 6 mL Vials. List Number 04943-04-01. Lot Codes and  ...
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Class II Some particles were observed in a limited number of OroCAM units. The particles if present could clog the pump mechanism and could also potentially result in under-administration. Abbott Laboratories
Food BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lot 2463 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Autumn Roast Exclusive Hot 5-5# Z, Product Item Number 1015-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2393, 2433, 2443, 2453, 2503, 2523, 2533, 2713, 2723, 2733 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley XXXHot 5-5# Z, Product Item Number 1020-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2283, 2333, 2343, 2413, 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM XHot 12-13 oz Z, Product Item Number 1021-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2333, 2763, 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 12-13 oz Z, Product Item Number 1022-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2163, 2243, 2253, 2423, 2473, 2583, 2593, 2743, 2753, 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Organic Mild 12-13 oz Z, Product item Number 1023-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lot 2233 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 12-13 oz Z, Product Item Number 1024-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2183, 2193, 2413, 2483, 2493, 2593, 2803, 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2383, 2393, 2433, 2443, 2453, 2523, 2543, 2733, 2773, 2783 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2113, 2523, 2533, 2543, 2773, 2783, 2843 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Blakes SuperHot 5-5# Z, Product Item Number 1028-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2743, 2753, 2763, 2863 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 28oz, Product Item Number 1032-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs. Lots 2143, 2173, 2613, 2633, 2683, 2693, 2703 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 28oz Z, Product Item Number 1034-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs. Lots 2143, 2173, 2323, 2603, 2623, 2683, 2693 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 6-56oz Z, Product Item Number 1042-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs. Lots 2263, 2353, 2403, 2833, 2863, 2873 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 6-56oz Z, Product Item Number 1044-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs. Lots 2413, 2643, 2663, 2673, 2883 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Exclusive XHot 6-56oz Z, Product Item Number 1048-5. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs. Lots 2653, 2663 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lot 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lot 2673 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC Exclusive Hot 5-5# Z, Product Item Number 1056-2. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lot 2763 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 5-5# Z, Product Item Number 1056-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2343, 2353, 2413, 2423, 2483, 2633, 2663, 2673, 2703, 2713, 2723, 2743, 2753, 2763, 2803, 2813, 2823, 2833, 2853, 2863, 2893 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Reserve Hot 5-5# Z, Product Item Number 1056-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2613, 2633 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Hot 5-5# Z, Product Item Number 1056-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2143, 2243, 2253, 2263, 2413, 2423, 2633 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 5-5# Z, Product Item Number 1056-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2143, 2163, 2213, 2243, 2253, 2263, 2333, 2343, 2403, 2413, 2703 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Exclusive Shot 5-5# Z, Product Item Number 1056-8. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2413, 2833 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC NO LABEL Mild 5-5# Z, Product Item Number 1057-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2683, 2873 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 5-5# Z, Product Item Number 1057-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2173, 2203, 2363, 2393, 2463, 2483, 2493, 2503, 2593, 2603, 2623, 2643, 2653, 2663, 2883 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Reserve Mild 5-5# Z, Product Item Number 1057-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2603, 2623 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Mild 5-5# Z, Product Item Number 1057-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2173, 2183, 2203, 2223, 2273, 2283, 2303, 2593, 2603, 2623 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 5-5# Z, Product Item Number 1057-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2203, 2223, 2363, 2503, 2583, 2683, 2173, 2203, 2213, 2223,2273, 2433, 2463, 2483, 2493, 2503, 2513, 2623, 2653, 2673,2763 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC Autumn Roast NO LABEL Hot 5-5# Z, Product Item Number 1062-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2773, 2783, 2843 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2133, 2293, 2373, 2453, 2533, 2543, 2573, 2733, 2773, 2783,2793, 2803, 2843, 2853, 2260, 2383, 2402 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2213, 2283 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Strip Mild 2-12.5# Z, Product Item Number 1071-4. Packaged in double-poly bags. Lots 2333, 2483, 2493, 2613 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Strip Hot 2-12.5# Z, Product Item Number 1072-4. Packaged in double-poly bags. Lots2273, 2283, 2343, 2603, 2633, 2703, 2743, 2883 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Whole Mild 2-12.5# Z, Product Item Number 1073-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs. Lots 2193, 2323, 2693, 2803 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Mild 2-12.5# Z, Product Item Number 1077-6. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs. Lots 2193, 2323, 2693, 2803 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 2-12.5# Z, Product Item Number 1081-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs. Lots 2573, 2583, 2593, 2693 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Autumn Roast Strip Medium 2-12.5# Z, Product Item Number 1090-5. Packaged in double-poly bags and not sealed. Lots 2373, 2383, 2393, 2433, 2503, 2543, 2773, 2783, 2793, 2843,2853 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 2-12.5# Z, Product Item Number 1093-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs. Lot 2203 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC 1.5 Hot 5-5# Z, Product Item Number 1096-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2323, 2613 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Devices Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile Catalog no. 2124-1400 All lots Class II Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle. Stryker Howmedica Osteonics Corp.
Devices ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA. Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459. Class II RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts. RTI Surgical, Inc.
Drugs Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. Lot# 605957A, Exp 09/14 Class II Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. Watson Laboratories, Inc.-(Actavis) - Florida
Drugs VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03. Lot #: 67603, Expiry: 2/2014 Class III Failed Stability Testing: This product is below specification for preservative content. Bracco Diagnostics Inc
Devices Product trade name t:slim" Insulin Delivery System Generic name Insulin Infusion Pump 510(k) Number K111210 cleared on Nov. 9, 2011 Description of the product - The Tandem t:slim" Insulin Delivery System (t:slim System or t:slim) is an Insulin Infusion Pump, product code LZG, per 21 CFR 880.5725. The t:slim System consists of the following components and accessories: (1) a software-controlled, programmable insulin infusion pump (t:slim Pump) capable of both basal and bolus delivery of insulin; (2) a dedicated, disposable 3mL (300 unit) insulin cartridge; (3) UnoMedicals Comfort" Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories including a Becton Dickinson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pumps internal battery, cartridge Instructions for Use, and Users Guide. Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120. Class I Tandem Diabetes Care®, Inc. announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim® Insulin Pump. The affected cartridges may be at risk for leaking. The cause of the recall was identified during Tandems internal product testing, and has not been associated with any complaints or adverse events reported by customers. However, a cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event. Tandem Diabetes Care Inc
Devices Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void A16707-098, A16707-099, A16707-100, A16707-101, A16707-102, A16707-103, A16707-104, A16707-105, A16707-106, A16707-107, A16707-108, A16707-109, A16707-110, A16707-111, A16707-112, A16707-113, A16707-114, A16707-115, A16707-116, A16707-117, A16707-118, A16707-119, A16707-120, A16707-121, A16707-122, A16707-123, A16707-124, A16707-125, A16707-142, and A16707-147 Class II Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm. Medtronic Sofamor Danek USA Inc
Food PASKESZ PREMIUM BELGIAN CHOCOLATE, KOSHER PARVE, Holographic Coins, Net Wt. 0.5 oz (14g) packaged in a carton containing 12 boxes with each box containing 24 mesh bags x 0.5 oz (14g) total weight 12 oz (336g), each mesh bag contains 5 pieces, ITEM 30178. MADE IN HOLLAND FOR: PASKESZ CANDY CO., Inc. Brooklyn, NY 11232. all lots Class I Paskesz Candy Co., Inc. has recalled PREMIUM BELGIAN CHOCOLATE coins due to Undeclared Milk. Paskesz Candy Co.,Inc.
Food Kinnikinnick Gluten Free Bread Crumbs Panko Style - gluten free, dairy free, nut free. 350g/12.5oz. UPC 62013360015 3 2 20140111, 2014AL20, and 2014JL23. The last two lot codes were part of the first expanded recall. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December, 2013. The 1/23/14 announcment states Up to and including Best Before 2014AU09, 20140809, and 140809. Class I Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free. Unified Western Grocers Inc
Food Kinnikinnick Gluten Free Pancake and Waffle Mix, gluten free, dairy free, nut free. 454 g/ 16 oz UPC 62013300512 2 20140502, and 20140417. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013. The 1/23/14 notice states up to and including Best Before 2015JA06, 20150106, and 150106. Class I Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free. Unified Western Grocers Inc
Food Kinnikinnick Gluten Free Original Homestyle Waffles Frozen Contains a logos on the package indicating it is gluten free, dairy free, and nut free. 210 g/7.4oz Qty/pkg - 6. UPC 62013300198 1. 2014AL15, 2014JN24, 2014MA07, and 2014JL29. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013. The new notification states Up to and including Best Before 2014AU10, 20140810, and 140810.. Class I Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free. Unified Western Grocers Inc
Food Kinnikinnick Gluten Free Cinnamon and Brown Sugar Homestyle Waffles - Frozen - gluten free, dairy free, nut free. 210 g/7.4oz Qty/pkg - 6 UPC 62013300199 8 2014AL15, 2014JN25, and 2014JL14. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013. The expanded recall notice dated 1/23/14 states up to and including 2014AU11, 20140811 and 140811. Class I Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free. Unified Western Grocers Inc
Devices GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH Model #882476, Serial #'s: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9228, 9229,  ...
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Class II The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study. Philips Medical Systems (Cleveland) Inc
Food Farm To Market Bread Co. San Francisco Sourdough, net weight 1 lb., unbleached enriched flour, water, sea salt, vitamin C. Farm to Market Bread Co., Kansas City, MO. No lot number or use by date. Class II The product label does not list wheat flour as an ingredient. Undeclared allergen. Farm To Market Bread Co Inc
Devices Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system. Model Number(s): 91-2109 (8.0 Plus) 91-2110 (Standard). Lot AL549784F: 91-2109 Malibu Polyaxial Screwdriver 8.0 Plus. Lot AL552404F: 91-2110 Malibu Polyaxial Screwdriver Standard. Lot AL546768F: 91-2110 Malibu Polyaxial Screwdriver Standard. The devices are not distributed as sterile and do not have a expiration date. Class II Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used. Integra LifeSciences Corp.
Food Panko Style Bread Crumbs, 12.5 oz, UPC 620133600153, NB Item #636886 Lot codes: 2013NO25 20131125 131125 2013NO26 20131126 131126 2013DE03 20131203 131203 2013DE11 20131211 131211 2013DE22 20131222 131222 2013DE23 20131223 131223 2013DE24 20131224 131224 2013DE30 20131230 131230 2014JA04 20140104 140104 2014JA11 20140111 140111 2014JA15 20140115 140115 2014JA19 20140119 140119 2014JA28 20140128 140128 2014JA29 20140129 140129 2014FE02 20140202 140202 2014FE09 20140209 140209 2014FE11 20140211 140211 2014FE19 20140219 140219 2014FE22 20140222 140222 2014MR11 20140311 140311 2014MR30* 2014AL27* 20140427* 2014AL15* 2014AL16* 2014AL20* 2014MA19* 2014JN11* 2014JL23* 2014MA21* 2014JN22*  ...
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Class I Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk. Natures Best Inc
Food Pancake and Waffle Mix, 16 oz, UPC 620133105122, NB Item#645556 Lot codes: 2014AL16 20140416 140416 2014AL17 20140417 140417 2014AL23 20140423 140423 2014AL24 20140424 140424 2014AL26 20140426 140426 2014AL29 20140429 140429 2014MA02 20140502 140502 2014MA06 20140506 140506 2014MA15 20140515 140515 2014MA16 20140516 140516 2014MA22 20140522 140522 2014MA30 20140530 140530 2014MA31 20140531 140531 2014JN03 20140603 140603 2014JN05 20140605 140605 2014JN10 20140610 140610 2014JN11 20140611 140611 2014JN13 20140613 140613 2014JN21 20140621 140621 2014JN28 20140628 140628 2014JL04 20140704 140704 140927* 2014SE27* 20140927* 2014OC15* 20141016* 2014OC16* 2014OC18* 141021*  ...
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Class I Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk. Natures Best Inc
Food Original Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001981, NB Item #616953 Lot codes: 2013DE09 20131209 131209 2013DE31 20131231 131231 2014JA26 20140126 140126 2014MR10 20140310 140310 2014MR15 20140315 140315 2014MR16 20140316 140316 2014AL15* 2014MA07* 2014JN24* 2014AL29* 2014JN10* 2014JL13* 2014JL29* Class I Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk. Natures Best Inc
Food Cinnamon and Brown Sugar Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001998, NB Item #616961. Lot codes: 2013DE25 20131225 131225 2014JA27 20140127 140127 2014AL15* 2014JN25* 2014AU10* 2014AL29* 2014JL13* 2014AU11* 2014MA28* 2014JL14* Class I Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk. Natures Best Inc
Food Bread & Bun Mix, 16.4oz, Qty/pkg: 6, UPC 620133105504, NB Item 645564 Lot codes: 2014AL04 20140404 140404 2014MA09 20140509 140509 140905* 2014NO20* 2014OC25* 2014DE19* Class I Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk. Natures Best Inc
Food Gourmet Bar in the following flavors: bacon, cayenne pepper, crispy orange, curry, mendiant dark, mendiant light Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com UPC Codes 729440332044, 729440332006, 729440332051, 729440332037, 729440332075, 729440332082 Class II Product may contain undeclared allergens Araya, Inc
Food Marshmallow in the following flavors: chocolate, coconut, cookies and cream, gingerbread, peppermint, red velvet, vanilla Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com UPC Codes 760921366004, 760921366011, 760921366066, 760921366003, 760921366097, 760921366073, 760921366028 Class II Product may contain undeclared allergens Araya, Inc
Food Dry fruits covered in chocolate in the following flavors: orange peel, mango cayenne, pear Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com UPC Codes 729440332082, 729440332105, 729440332136 Class II Product may contain undeclared allergens Araya, Inc
Food Chocolate Gift Boxes: SC 6 Oreos, SC Small 12 Chocolate, SC Small 6 chocolate Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com UPC Codes 729440332167, 729440332488, 729440332235 Class II Product may contain undeclared allergens Araya, Inc
Food Chocolate S'mores Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com UPC Code 729440332402 Class II Product may contain undeclared allergens Araya, Inc
Devices Horizon Medical Imaging, Picture Archive Communication System (PACS). HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9. Class II Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive. Mckesson Information Solutions LLC
Food Pringles, the Original, Net Weight 5.68 oz (161 g) UPC code 0 38000 84496 6 Ingredients: INGREDIENTS: DRIED POTATOES, VEGETABLE OIL (CONTAINS ONE OR MORE OF THE FOLLOWING: CORN OIL, COTTONSEED OIL, SOYBEAN OIL, AND/OR SUNFLOWER OIL), CORN FLOUR, WHEAT STARCH, MALTODEXTRIN, SALT, RICE FLOUR AND DEXTROSE. CONTAINS WHEAT INGREDIENTS Product was placed in 226 display shippers with a variety of Pringles products. PRINGLES US 4-FLV 84ct ALT SHPR UPC 38000 84832 PRINGLES US 3FLV MXD 728/164G PALLET UPC 38000 84620 individual cans codeL 3269KT70 0830 - L 3269KT70 0930 BEST BY 12/26/2014 Manufacturing Code on Shippers PRINGLES US 4-FLV 84ct ALT SHPR KT 12064C and KT12074A PRINGLES US 3FLV MXD 728/164G PALLET KT 12264 Class I Undeclared milk, an allergen Kellogg Company
Food Panko Style Bread Crumbs net wt. 350g 12.5 oz. gluten free, dairy free, nut free Up to and including Best Before 2014AU09, 20140809, 140809 Class I contains undeclared milk Braum's Ice Cream and Dairy
Food Gorgonzola Gems Jalapeno Peppers With Gorgonzola and Cream Cheese Blend 8 oz. (227 g) packages, 6/pack Lot #'s 1024020A and 1023020B (Products also contain a BEST BEFORE NOV 15 14 code, and UPC code 2113010895) Class II product has the potential to be contaminated with Listeria monocytogenes Windsor Frozen Foods
Devices Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone. 510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB Class II Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital. Stryker Howmedica Osteonics Corp.
Drugs Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL Sterile Water for Injection, USP per carton (NDC 52544-188-76), 11.25 mg, Rx Only, Dist. By: Watson Pharma, Inc., Morristown, NJ 07962, Mfd. by: Debio RP, CH-1920 Martigny, Switzerland. Lot #: 13J081, Exp 05/15 Class II Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg. Actavis Inc
Food Gano C'Real Spirulina, Net Wt. 450g (30gx15 sachets) Lot: 290712 (290712 MFG July 2012) Class I Gano Excel USA is recalling the C'Real Spirulina because it contains undeclared wheat and soy. Gano Excel USA Inc
Biologics Bermuda Grass B29032613; Class III One lot of Standardized Bermuda Grass Pollen Allergenic Extract, with a decreased potency, was distributed. Antigen Laboratories Inc
Drugs Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01 Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14 Class II Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification. Mylan Pharmaceuticals Inc.
Drugs Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI.... Lot #: JKM7075A, Expiry:10/15 Class II Failed Tablet Specifications: Broken Tablets Present. Caraco Pharmaceutical Laboratories Ltd.
Devices Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121. 16397693 Class II Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. The most common adverse health consequence resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention. Boston Scientific Corporation
Devices Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151. 16310947 Class II Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. The most common adverse health consequence resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention. Boston Scientific Corporation
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