Digital Temple Thermometer (DTT) by K-Jump Health Co., Ltd.: Recall

[Posted 12/01/2015] AUDIENCE: Consumer, Pediatrics ISSUE: Bestmed, LLC, a medical device distributor, initiated a nationwide recall of the Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co., Ltd, featuring lot numbers S/N: 3612 through S/N: 3715, which were sold between October 2012 until the start of the recall in November 2015. Some Digital…

Intravascular Medical Devices: FDA Safety Communication

Including medical devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems [Posted 11/23/2015] AUDIENCE: Risk Manager, Cardiology, Surgery, Radiology, Pathology ISSUE: The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical…

G5 Ventilator by Hamilton: Class I Recall

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Plavix (clopidogrel): Drug Safety Communication – Long

[Posted 11/06/2015] AUDIENCE: Cardiology, Hematology, Surgery ISSUE: An FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does…

Auvi-Q (epinephrine injection, USP): Recall

[Posted 10/29/2015] AUDIENCE: Pharmacy, Patient ISSUE: Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The…