—#25387

Product

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 product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K003245
Affected lot / code info: all lots within expiration date

Why it was recalled

Sterility questioned

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide, Canada, Honduras, Indonesia, Israel

Timeline

Recall initiated: 2002-12-12
Posted by FDA: 2003-01-23
Terminated: 2004-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #25387. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.