Class 1 Device Recall B. Braun

• Date Initiated by Firm: December 11, 2007
• Date Posted: January 30, 2008
• Recall Status: Terminated on December 02, 2010
• Recall Number: Z-0836-2008
• Recall Event ID: 46182
• Product Classification: Saline IV Flush Pre Filled Syringe - Product Code FOZ
• Product: B. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524
• Code Information: ALL LOTS
• Recalling Firm/ Manufacturer: AM2 PAT INC; 455 W Depot Street; Angier NC 27501
• For Additional Information Contact: Dushyant Patel; 919-552-9689
• Manufacturer Reason for Recall: Lack of assurance of sterility by manufacturer
• FDA Determined Cause: Process design
• Action: AM2PAT contacted their distributors by phone on or about January 17, 2008 and instructed them to stop distribution of their pre-filled syringes and to contact their customers to recall all AM2PAT manufactured lots and all sizes of prefilled, Heparin Lock Flush syringes and Normal Saline IV Flush syringes (B Braun and Sierra Brands) to the consumer level. A press release was issued on January 17, 2008. The firm had eariler on 12/20/2007 recalled a single lot of Heparin syringes, the January extension was to all lots/all sizes of its Heparin and Saline syringes.
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.