HIGH
CPSC
Petzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or Death from Fall Hazard
Petzl America
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HIGH
FDA DEVICE
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon...
ConMed
Potential for
HIGH
FDA DEVICE
ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon...
ConMed
Potential for
HIGH
FDA DEVICE
ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon...
ConMed
Potential for
HIGH
FDA DRUG
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
NICOTINE
Failed Impurities/Degradation
HIGH
FDA DEVICE
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code:...
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Abiomed
Potential software
HIGH
FDA DRUG
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
DULOXETINE
CGMP Deviations;
HIGH
FDA DRUG
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
EPINEPHRINE
Failed Impurities/Degradations
HIGH
FDA DEVICE
ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon...
ConMed
Potential for
HIGH
FDA FOOD
Salt
Plain salt was labeled as iodized and iodized salt was labeled as plain.
United Salt
Plain salt
HIGH
FDA DEVICE
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central...
Due to 11 volt Backup Battery failures.
Thoratec
Due to
HIGH
FDA DEVICE
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular...
Due to 11 volt Backup Battery failures.
Thoratec
Due to
HIGH
FDA DEVICE
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup...
Due to 11 volt Backup Battery failures.
Thoratec
Due to
HIGH
FDA DEVICE
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Medtronic Neuromodulation
A limited
HIGH
FDA DEVICE
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Medtronic Neuromodulation
A limited
HIGH
FDA FOOD
Hellas Meze Golden Smoked Whole Herring
Un-eviscerated fish may be contaminated with clostridium botulinum
Terra Medi
Un-eviscerated fish
HIGH
FDA FOOD
Nutrisystem, Chocolate Cheesecake, 2 oz (57g) packages, Flow Wrapped, 48 units per case, Keep frozen
Nutrisystem
Undeclared Allergen
HIGH
FDA FOOD
Pearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panqueques y Waffles) Net Wt 5.99 oz (170 g). Packed in 50 - 5.99 oz BOPP Pouch units per master case. Keep in a cool, dry...
Undeclared allergens: Milk and Soy
CERELES EN GENERAL SAS
Undeclared allergens:
HIGH
HIGH
FDA DEVICE
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Fresenius Medical Care Holdings
Given the