FDA 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.
Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)
Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.
The firm plans to provide corrections via removal/replacement of the affected units directly to end users in the U.S. and work with distributors to perform removal and correction abroad.
Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label.
The demand valve is defective and does not function as intended in the 'Conservative Mode'.
The firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements.
7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.
Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).
The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
On 9/21/05, the firm issued letters via UPS to all its direct consignees, informing them of the affected product and providing instructions on the recall.