Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on via
FDA device recall Z-1384-2008 · posted 2008-04-04 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- NZW
- Quantity affected
- 335,860 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 who
- Date initiated
- 2008-02-28
- Date posted
- 2008-04-04
- Date terminated
- 2020-02-18
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.