Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall Z-1386-2008 · Posted 2008-04-04
Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeNZW
Date Initiated2008-02-28
Date Terminated2020-02-18
Product Quantity262,450 vials
Reason for Recall
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
Firm 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
Root Cause
Nonconforming Material/Component
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.