Recall Z-0456-03 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Baxter Healthcare Corp.
0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
| Date | Jan 23, 2003 (initiated Dec 12, 2002) |
| Status | Terminated |
| Reason | Sterility questioned |
| Root cause | Other |
| Action | Recalled by letter dated 12/12/02. Customers were informed of the compromised sterility of all lots of the listed products within expiration date, and were requested to destroy all lot numbers of the identified product codes. Baxter will issue their customers credit for the product destroyed. |
| Quantity | 51,052,140 syringes |
| Distribution | Nationwide, Canada, Honduras, Indonesia, Israel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984590 | 0.9% SODIUM CHLORIDE FLUSH SYRINGE Baxter Healthcare Corp, Oct 7, 1999 |