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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Vacuette, Safety Blood Collection Set with Luer Adapter see related information
Date Initiated by Firm March 10, 2003
Date Posted May 09, 2003
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = GREINER VACUETTE NORTH AMERICA, INC.
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