Class 2 Device Recall BD Integra

• Date Initiated by Firm: January 27, 2007
• Date Posted: March 03, 2007
• Recall Status: Terminated on July 24, 2007
• Recall Number: Z-0582-2007
• Recall Event ID: 37248
• 510(K)Number: K023752
• Product Classification: Insulin Syringe - Product Code FMF
• Product: BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2'' (0.33mm x 13 mm) Re-Order No. 305282 U-100 insulin Lot 6073436
• Code Information: Lot # 6073436 Ref (Reorder number) 305282)
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Greg Morgan; 201-847-4344
• Manufacturer Reason for Recall: The needle becomes detached from the hub/syringe
• FDA Determined Cause: Other
• Action: Recall notification letters were sent via UPS second day air on January 27, 2007. Distributors were asked to provide end user contact information to recalling firm.
• Quantity in Commerce: 247,824 units
• 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.

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