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U.S. Department of Health and Human Services

Class 2 Device Recall Winged Blood Collection Holdex Set

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  Class 2 Device Recall Winged Blood Collection Holdex Set see related information
Date Initiated by Firm December 16, 2003
Date Posted January 29, 2004
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = GREINER MEDITECH, INC.
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