Class 2 Device Recall Winged Blood Collection Holdex Set

• Date Initiated by Firm: December 16, 2003
• Date Posted: January 29, 2004
• Recall Status: Terminated on June 07, 2004
• Recall Number: Z-0388-04
• Recall Event ID: 28126
• 510(K)Number: K992145
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.
• Code Information: Item #450271, Lot #12-8461
• FEI Number: 3001451379
• Recalling Firm/ Manufacturer: Greiner VACUETTE North America; 4238 Capital Dr; Monroe NC 28110-7681
• For Additional Information Contact: Manfred Pillichshammer; 704-261-7823
• Manufacturer Reason for Recall: Product may have a defective connection.
• FDA Determined Cause: Other
• Action: Distributors and end users were notified by certified mail or fax on 12/16/2003.
• Quantity in Commerce: 5 cases (5000 pieces)
• Distribution: The product was shipped to medical facilities in IN, NY and TX.
• 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 = FPA