Recall Z-0800-05 ยท CAZ Anesthesia Conduction Kit
Baxter Healthcare Corp.
Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | May 6, 2005 (initiated Mar 28, 2005) |
| Status | Terminated |
| Reason | The anesthesia trays contain BD 25G Spinal Needles which which have leakage at the plastic hub of the needle. |
| Root cause | Other |
| Action | Urgent Device Correction letters dated 3/28/05 were sent to the direct accounts via first class mail. The accounts were informed of the leakage associated with the plastic hub of the spinal needle contained in the trays, and were provided with a listing of product codes and lots numbers of the spinal trays affected. The accounts were instructed to check their inventory for the affected trays and to contact BD at 1-888-237-2762 for instructions on how to obtain replacement spinal needles. Replacement needles will be shipped overnight, and the accounts were instructed to remove and destroy th |
| Quantity | 127,340 trays |
| Distribution | Nationwide, Puerto Rico, Amaerical Samoa, Guam, Canada and Venezuela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.