Recall Z-1229-2007 ยท MPB Catheter, Hemodialysis, Non-Implanted
C.R. Bard Access Systems, Inc
Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.
| Date | Sep 20, 2007 (initiated Aug 10, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard. |
| 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). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K844433 | VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA Vas-Cath of Canada , Ltd., Mar 13, 1985 |