Class 2 Device Recall Vacuette, Safety Blood Collection Set with Luer Adapter

• Date Initiated by Firm: March 10, 2003
• Date Posted: May 09, 2003
• Recall Status: Terminated on August 07, 2003
• Recall Number: Z-0797-03
• Recall Event ID: 25738
• 510(K)Number: K011786
• Product Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
• Product: Vacuette, Safety Blood Collection Set with Luer Adapter
• Code Information: Item no. 450096, Lot #''s 02I09C, 02I11C and 02I20C
• Recalling Firm/ Manufacturer: Greiner VACUETTE North America; 4238 Capital Drive; Monroe NC 28112
• For Additional Information Contact: Manfred Pillichshammer; 704-261-7823
• Manufacturer Reason for Recall: The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
• FDA Determined Cause: Other
• Action: Consignees were notified via certified letter on/about 3/6/2003 and were advised to stop distributing the product immediately and to discard any remaining product in stock.
• Quantity in Commerce: 139000 units
• Distribution: Product was distributed to medical facilities 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 = JKA