Z-0458-03

100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per...

Name: Z-0458-03 100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per...
Creator: Baxter Healthcare Corp.
Published: 2002-12-12
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2002-12-12 / Terminated / root cause: sterility

FDA source

Baxter Healthcare Corp. began a recall of 100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case on 2002-12-12. The reason FDA records is "Sterility questioned". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0458-03
Status: Terminated
Initiated: 2002-12-12
Posted: 2003-01-23
Terminated: 2004-06-29
Recalling firm: Baxter Healthcare Corporation
Product: 100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Sterility questioned
Root cause tag: sterility
FDA 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 in commerce: 727,560 syringes
Distribution: Nationwide, Canada, Honduras, Indonesia, Israel
Product codes and lots: all lots within expiration date of the following pre-filled syringes: Code 2K6049: 3 mL in 12 mL syringe Code 2K6050: 5 mL in 12 mL syringe Code 2K6058: 5 mL in 12 mL syringe w/cannula

Product code FOZ

K003245Class IIHeparin Lock Flush Syring 10 Usp Units/ml, Heparin Lock Flush Syringe, 100 Usp Units/mlBaxter Healthcare Corp / cleared 2000-12-04

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)