Pre-Filled Heparin Lock Flush Solution syringes recalled
On December 20, 2007, Angier, North Carolina-based AM2 PAT, Inc. initiated a nationwide recall of one lot of their Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot #070926H. The syringes were found to be contaminated with Serratia marcescens by the Centers for Disease Control (CDC). Serratia marcescens may cause a potentially fatal bacterial infection.
According to the FDA, consumers and facilities with the recalled Pre-Filled Heparin Lock Flush Solution syringes should immediately cease usage of the product, and quarantine and return the syringes to their distributor immediately.
The Pre-Filled Heparin Lock Flush Solution USP syringe recall includes Heparin Lock Flush Solution USP, 100units/mL, 5mL in pre-filled syringes, manufactured by Angier, North Carolina-based Sierra Pre-Filled, Inc. The affected products are from lot number 070926H. The NDC number is 64054-1003-02 and the catalog number is 1003-02.
The syringes were distributed nationwide, specifically including the states of Florida, Texas, Illinois, Colorado, and Pennsylvania.
According to the FDA, AM2 PAT, Inc?s facility is not in compliance with the FDA?s Quality System regulation. It reports that AM2 PAT failed to maintain sterility of its pre-filled syringe products.
Concerned consumers may contact AM2 PAT, Inc. at 1-919-552-9689 or 847-691-6500 Monday through Friday 9AM to 5PM EST.
The FDA asks that all adverse reactions experienced as a result of usage of this product be reported to the FDA?s MedWatch program at 1-800-FDA-1088.
Source: U.S. Food and Drug Adminstration, ?AM2 PAT, Inc. Issues Nationwide Recall of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes),? December 24, 2007.
