FDA Device Recalls in 2006
456 recalls found
January 2006
Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.
The coil is 20 centimeters in length, but the label states the length is 20 millimeters.
Consignees were notified via telephone and recall letter dated September 26, 2005.
Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device
Notification to customers sent via FedEx on July 5, 2005, with product handling instruction sheet. Follow up communications to non-returning consignees will be recorded and documented.