Class 2 Device Recall Normal Saline 10ml in 12ml Syringe

• Date Initiated by Firm: July 30, 2007
• Date Posted: September 20, 2007
• Recall Status: Terminated on April 01, 2008
• Recall Number: Z-1236-2007
• Recall Event ID: 39386
• 510(K)Number: K002142
• Product Classification: saline flush syringe - Product Code NGT
• Product: Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton.
• Code Information: Item number 531587. Lot numbers 070507SFR exp 5/09, 070523SFR exp 5/09 070529SFR exp 6/09, 070601SFR exp 6/09, 070605SFR exp 6/09, 070608SFR exp 6/09, 070613SFR exp 6/09, 070618SFR exp 6/09, 070620SFR exp 6/09, and 070625SFR exp 6/09.
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Boulevard; Allentown PA 18109-9512
• For Additional Information Contact: Kimberly Paris; 610-266-0500
• Manufacturer Reason for Recall: Particulate matter in product.
• FDA Determined Cause: Other
• Action: The recalling firm issued a Product Removal Notice to the distributors on 7/31/07 informing them of the problem and the need to contact their customers. Product should be returned to the recalling firm for destruction. On 9/14/07, the recalling firm issued a press release to alert any consumer that may have the product of the particulate problem.
• Quantity in Commerce: 1,292,520 units
• Distribution: The products were shipped to distributors 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.

• 510(K) Database: 510(K)s with Product Code = NGT