Recall Z-0457-03 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Baxter Healthcare Corp.
10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL Syringe, code 2K6030; 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 | 388,080 syringes |
| Distribution | Nationwide, Canada, Honduras, Indonesia, Israel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003245 | HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML Baxter Healthcare Corp, Dec 4, 2000 |