Cook Medical recalls
more than 4 million catheters due to polymer degradation.
Medscape (5/4, Brooks, 302K) says Cook Medical
“has voluntarily recalled 4,146,309 catheters with Beacon Tip technology
because of reports of polymer degradation of the catheter tip,” according to
the Food and Drug Administration. The polymer degradation can result in “tip
fracture and/or separation,” which can cause “loss of device function,
separation of a device segment leading to medical intervention, or
complications resulting from a separated segment.” So far, Cook Medical has
received 30 reports about the defect.
No comments:
Post a Comment