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Terminated

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

FDA Recall Z-0458-03 · Posted 2003-01-23

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFOZ
Date Initiated2002-12-12
Date Terminated2004-06-29
Product Quantity727,560 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.

K003245HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/MLBaxter Healthcare Corp · 2000-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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