Recall Z-1391-2008 ยท NZW Heparin, Vascular Access Flush
Baxter Healthcare Corp.
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25 pack, NDC 0641-2443-45, (NDC 0641-2443-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Apr 4, 2008 (initiated Feb 28, 2008) |
| Status | Terminated |
| Reason | Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products |
| Root cause | Nonconforming Material/Component |
| Action | A Press Release was issued on February 28, 2008. Recall notification letters , Urgent Product Recall, were sent on February 29, 2008, by overnight mail to customers/wholesalers/ distributors and dialysis center/renal home patients. Recall letters were also sent on March 7, 2008, to health care professionals |
| Quantity | 211,662 vials |
| Distribution | Worldwide Distribution --Worldwide: USA including Puerto Rico, and countries of Germany, Guam, America Samoa, Marshal Islands, Northern Mariana Island/Virgin Islands, and Qatar . Accounts included wholesalers, pharmacies, hospitals, and clinic/renal home patients |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.