Reusable fingerstick (blood lancing) devices and point of care (POC) blood testing devices (e.g., blood glucose meters, PT/INR anticoagulation meters, cholesterol testing devices) blood testing devices. Fingerstick and POC blood testing devices used on more than one patient may not be safe for several reasons. Improper use or device malfunction can lead to the […]
INOMAX DS Drug-Delivery System: Class I Recall – Risk of Interruption of Drug Flow
[Posted 08/23/2010] AUDIENCE: Pulmonology, Risk Manager ISSUE: Ikaria, Inc. notified healthcare professionals of a Class I Recall of the INOMAX (nitric oxide) Drug-Delivery System. There is a potential for failure of a pressure switch which may have an impact on the administration of INOMAX for inhalation to patients. Risks to the patient may include interruption of […]
6 French Engage Introducer Devices by St. Jude Medical: Recall – Potential for Separation of Shaft From Hub
[Posted 08/13/2010] AUDIENCE: Risk Manager, Surgery, Cardiology ISSUE: Some devices in the affected batches have the potential for separation of the shaft (sheath) from the hub or for a break in the hub assembly. If either of these were to occur during use, a potentially life threatening episode of bleeding could occur. BACKGROUND: The Engage […]
Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product
AUDIENCE: Emergency Medicine, Consumers ISSUE: FDA has become aware of suspected counterfeit C-A-T® tourniquets which have subtle differences in stitching, printing of the logo and molding of plastic parts. Preliminary testing has shown that the suspected counterfeit tourniquet does not perform the same as the tourniquet manufactured by Composite Resources. The windlass is weaker in […]
Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use
AUDIENCE: Emergency Medicine, Surgery ISSUE: Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These […]
Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach
[Posted 07/30/2010] AUDIENCE: Consumers, Emergency Medicine ISSUE: FDA warned consumers not to consume or use Miracle Mineral Solution, an oral liquid solution also known as “Miracle Mineral Supplement” or “MMS.” The product, when used as directed, produces an industrial bleach that can cause serious harm to health. The product instructs consumers to mix the 28 percent […]
Evamist (estradiol transdermal spray): Drug Safety Communication – Unintended Exposure of Children and Pets to Topical Estrogen
[Posted 07/29/2010] AUDIENCE: OB/GYN, Patient ISSUE: FDA notified healthcare professionals and patients that it is reviewing reports of adverse effects from Evamist, an estrogen hormone used to reduce hot flashes during menopause. Children unintentionally exposed to the drug through skin contact with women may experience premature puberty. Female children may experience nipple swelling and breast development. Male […]
Cubicin (daptomycin): Drug Safety Communication – Risk of Eosinophilic Pneumonia
[Posted 07/29/2010] AUDIENCE: Infectious Disease, Pulmonology ISSUE: FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug indicated for use in treatment of serious skin infections and bloodstream infections. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell […]
Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays
Sets and Trays contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube [Posted 07/22/2010] Audience: Hospital Risk Manager, Anesthesiology Issue: FDA notified healthcare professionals that Cook initiated a voluntary recall of certain lots of Ciaglia Blue Rhino/Blue Dolphin Percutaneous Tracheostomy Introducer Sets/Trays that contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube due to the product’s cuff […]
Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient
Posted [07/22/2010] Audience: Consumers Issue: FDA lab analysis of this herb supplement was found to contain the undeclared drug, desmethyl sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with […]