Z-1393-2008

Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack, NDC...

Name: Z-1393-2008 Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack, NDC...
Creator: Baxter Healthcare Corp.
Published: 2008-02-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2008-02-28 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial), Baxter... on 2008-02-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1393-2008
Status: Terminated
Initiated: 2008-02-28
Posted: 2008-04-04
Terminated: 2020-02-18
Recalling firm: Baxter Healthcare Corporation
Product: Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Product code: NZW Heparin, Vascular Access Flush
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
Root cause tag: manufacturing process
FDA 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 in commerce: 689,725
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
Product codes and lots: All Lots

Product code NZW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)