10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL Syringe, code 2K6030; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
FDA Recall Z-0457-03 · Posted 2003-01-23
Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFOZ
Date Initiated2002-12-12
Date Terminated2004-06-29
Product Quantity388,080 syringes
Reason for Recall
Sterility questioned
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, Canada, Honduras, Indonesia, Israel
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.