—#69281

Product

Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA product code: NZW — Heparin, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: All Lots

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2008-02-28
Posted by FDA: 2008-04-04
Terminated: 2020-02-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69281. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.