Recall Z-1229-2007

C.R. Bard Access Systems, Inc · initiated August 10, 2007

Terminated

Product

Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.

Codes / lots: Product Code 5583705, Lot Numbers: 22FMA202, 22IMO531, 22KMO573, 22DN2914, 22FN5232, 22GN5835, 22GN5878, 22HN6574, 22BO6078, 22BO6163, 22FO6086, 22GO6026, 22HO6101, 22IO6111, 22KO6124, 22CP6268, 22EP6831, REPG0035, REPG0643, REPH0954, REPK0058, REPK0729, REPL0298, REQB0030, REQB0224, REQD0200, REQF0429, REQF0736, REQJ0282, REQK0875, RERC0052, RERD0719.

Reason for recall

Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.

FDA-determined cause: Other

Action taken

Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard.

Details

Recall number: Z-1229-2007
Initiated: August 10, 2007
Posted by FDA: September 20, 2007
Terminated: April 25, 2008
Product code: MPB – Catheter, Hemodialysis, Non-Implanted
Quantity: 7225 units
Distribution: Worldwide, including USA, Canada, Latin America, and Europe (Austria, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, and Sweden).
Recalling firm: C.R. Bard Access Systems, Inc, Salt Lake City, UT

Official FDA recall record