Baxter ($BAX) has launched a voluntary recall of some poorly packaged medical caps it said can lead to embolism, and the FDA warns that using the devices could cause serious injury or death.
At issue are the Dual Luer Lock Caps, twist-on seals used to close access points in medical devices and IV sets. Baxter is recalling some of the caps over concerns that loose particulate matter slipped into the packaging. If such matter enters the bloodstream, patients risk pulmonary embolism, myocardial infarction and stroke, the company said.
Baxter is asking customers to return caps from two lots--10043 and 10044--so that it may replace them. The company figures its recall will have no material financial impact.
The FDA has labeled the recall a Class I, a designation the agency reserves for malfunctions that can result in serious adverse events including death.
Baxter said it's yet to hear any reports of injuries stemming from the problem, but the company acknowledges that it would be hard to attribute an embolism to some stray particulate matter. The FDA is asking customers and patients to report any adverse events through its MedWatch system.
The cap issue is Baxter's second bit device-related FDA woe this year, following a warning letter the company received in April for marketing an infusion pump without agency approval.
- read Baxter's statement