here are a few FDA recalls you might want to know…. 1. Class 1 Recall for Carefusion Alaris Infusion Pump Model 8015 – read notice here The issue: FDA notified healthcare professionals of a Class I Recall of the Alaris PC unit, model 8015. A component on the PC unit power supply board is causing…
A Class I recall has been issued for the SynchroMed II Implantable Infusion Pump, models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011 manufactured by Medtronics Inc. The SynchroMed II Pump is indicated when patient therapy requires the chronic infusion of the drugs or fluids. This infusion pump is indicated to deliver…
In the past weeks, there have several FDA alerts and recall notices related to products used in infusion therapy. Here are some of the products. Class I Recall: CareFusion Corporation, Alaris PC Units (Model 8015) Reason for Recall: Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This…
Certain lots of Epogen and Procrit (Epoetin alfa) vials are being recalled as a precaution, because the vials may contain extremely thin glass flakes (lamellae) that are barely visible. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular…
There is an FDA Class I recall of Symbig Infusion Pumps One channel, model 16026 and Dual channels, model 16027 made by Hospira due to the potential for unrestricted flow of fluid or medication if the administration set (cassette) is removed before the cassette carriage fully opens and the slide/roller clamp is not closed. Additionally,…
A Class I recall is the most serious type of recall. In a Class I recall, there is a reasonable chance that the product will cause serious health problems or death. The FDA issued a Class I recall of the following huber needles: Multi-Med, Inc. 22 Gauge x 1 inch straight Huber needles Model 10600218,…
On July 13, 2010, the U.S. Food and Drug Administration required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination. According to the FDA, it is requiring Baxter to provide…
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals not to use certain intravenous (IV) bags of metronidazole, ondansetron, and ciprofloxacin because of potential contamination. FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India. Microbiological analysis identified the matter in one of the bags…
An FDA press release stated that Acacia Inc. voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. The BD Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company). The IV Extension Set with BD Q-Syte™ Luer Access device is intended…
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