FDA recalls, November 2016: 312 published

104 different companies appear this month.

Risk classification: Class I: 66 · Class II: 202 · Class III: 44

Same month, other agencies:CPSC 27 recallsFSIS 15 recallsNHTSA 73 recalls

Recalls this month

DateProduct
November 30, 2016HCG Complex. 2oz HCG Drops. Blue Plastic.F-0493-2017Infiniti Creations, LLC
November 30, 2016Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in…D-0146-2017VistaPharm, Inc.
November 30, 2016HCG Plus. 2oz HCG Drops. Blue GlassF-0483-2017Infiniti Creations, LLC
November 30, 2016Buffets Corn Muffin Mix, 30# BagF-0508-2017CSM Bakery Products NA
November 30, 2016Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, …D-0153-2017Hospira Inc.
November 30, 2016Brill White Crm Cake Mix, 50#F-0523-2017CSM Bakery Products NA
November 30, 201611644 Ultra Rich Creme Cake Mix, 50#F-0518-2017CSM Bakery Products NA
November 23, 2016CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, It…Z-0531-2017ICU Medical, Inc.
November 23, 2016TRANSPAC¿ IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (…Z-0433-2017ICU Medical, Inc.
November 23, 2016MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 The Transpac D…Z-0514-2017ICU Medical, Inc.
November 23, 2016Orange Cake, Net Wt. 10 oz. (283g), UPC 7 80890 28604 2.F-0460-2017Nobel Bakery
November 23, 2016SAUER'S BARBEQJ E SPICE, 3 oz.F-0444-2017C.F. Sauer Company
November 23, 2016SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17 Th…Z-0456-2017ICU Medical, Inc.
November 23, 2016The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used …Z-0413-2017Sorin Group USA, Inc.
November 23, 2016SAUER'S CHILl POWDER, 5.5 lbs. BLUE MOUNTAIN VALLEY CHILl POWDER, 5.5 lbs. CHEF'S …F-0447-2017C.F. Sauer Company
November 23, 2016Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 The Transpa…Z-0455-2017ICU Medical, Inc.
November 23, 2016Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Y…Z-0566-2017ICU Medical, Inc.
November 23, 2016Simply Balanced brand White Chicken Chili dry soup mix. This is not a ready to eat produ…F-0455-2017Conifer Specialties, Inc.
November 23, 2016PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65 T…Z-0470-2017ICU Medical, Inc.
November 23, 2016FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate …Z-0587-2017Inpeco S.A.
November 23, 2016TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, …Z-0447-2017ICU Medical, Inc.
November 23, 2016White Cheddar Cheese, 40 lb. blocksF-0428-2017Farm Country Cheese House, Inc.
November 23, 2016CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pre…Z-0507-2017ICU Medical, Inc.
November 23, 20162 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Ite…Z-0533-2017ICU Medical, Inc.
November 23, 2016Dimension Vista IRON Flex reagent cartridgesZ-0401-2017Siemens Healthcare Diagnostics, Inc.
November 23, 2016CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No.…Z-0520-2017ICU Medical, Inc.
November 23, 2016PRIME TIME Cucumbers, 1 & 1/9 BUSHEL CARTON, 25kg per carton, TAG ID# 10173318, 10173319,…F-0476-2017Prime Time International
November 23, 2016FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufa…D-0138-2017CutisPharma, Inc.
November 23, 2016OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System wi…Z-0610-2017OMNI LIFE SCIENCE
November 23, 2016TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (IN…Z-0430-2017ICU Medical, Inc.
November 23, 2016Marble Cheese, thirty-three 40 lb. blocksF-0432-2017Farm Country Cheese House, Inc.
November 23, 2016Baptista Bakery & Pastry Inc. Bulkie Rolls, 16 oz. plasticF-0473-2017Batista Bakery & Pastries, Inc.
November 23, 2016Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Tr…Z-0548-2017ICU Medical, Inc.
November 23, 2016Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way St…Z-0569-2017ICU Medical, Inc.
November 23, 2016ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The Tr…Z-0475-2017ICU Medical, Inc.
November 23, 2016TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transp…Z-0524-2017ICU Medical, Inc.
November 23, 2016Pappion, Net Wt. 10 oz. (283g), UPC 7 80890 28612 7.F-0466-2017Nobel Bakery
November 23, 2016SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definitio…Z-0608-2017Siemens Medical Solutions USA, Inc
November 23, 2016SAUER'S GROUND CUMIN,5lbs . CHEF'S MAGIC GROUND CUMIN, 5 lbs. CODE GROUND CUMIN, 5 lbs. …F-0451-2017C.F. Sauer Company
November 23, 2016POLLOTROPICAL TUMBLE MARINADE, 21.25 lbs.F-0450-2017C.F. Sauer Company
November 23, 2016DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable…Z-0535-2017ICU Medical, Inc.
November 23, 2016ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Cent…Z-0612-2017Siemens Healthcare Diagnostics, Inc
November 23, 2016Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled…Z-0609-2017Trilliant Surgical Ltd.
November 23, 2016TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP A…Z-0549-2017ICU Medical, Inc.
November 23, 2016TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-2…Z-0494-2017ICU Medical, Inc.
November 23, 2016CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Disposable Stra…Z-0466-2017ICU Medical, Inc.
November 23, 2016PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51 The Transpac Disposable Straight Pres…Z-0505-2017ICU Medical, Inc.
November 23, 2016iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.Z-0611-2017Merge Healthcare, Inc.
November 23, 2016CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Trans…Z-0500-2017ICU Medical, Inc.
November 23, 2016Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA …Z-0406-2017C.R. Bard, Inc.

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