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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 Adaptersee related information
Date Initiated by FirmMarch 10, 2003
Date PostedMay 09, 2003
Recall Status1 Terminated 3 on August 07, 2003
Recall NumberZ-0797-03
Recall Event ID 25738
510(K)NumberK011786 
Product Classification Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
ProductVacuette, Safety Blood Collection Set with Luer Adapter
Code Information Item no. 450096, Lot #''s 02I09C, 02I11C and 02I20C
FEI Number 3001451379
Recalling Firm/
Manufacturer		 Greiner VACUETTE North America
4238 Capital Drive
Monroe NC 28112
For Additional Information ContactManfred 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
ActionConsignees 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 Commerce139000 units
DistributionProduct was distributed to medical facilities Nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JKA
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