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U.S. Department of Health and Human Services

Class 2 Device Recall HOLDEX

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  Class 2 Device Recall HOLDEX see related information
Date Initiated by Firm May 16, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on August 21, 2009
Recall Number Z-2134-2008
Recall Event ID 48455
510(K)Number K980768  
Product Classification Intravascular administration set - Product Code FMI
Product Vacuette, Plastic Cannula HOLDEX¿, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the holder. It is intended for use in routine specimen withdrawal from collection bags or bottles through needless cannula ports.
Code Information Item #450216, Lot #A10074, A100745, A100746, A100747, A110749, and A110750.
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110-7681
For Additional Information Contact Mr. Manfred Abel
704-261-7823
Manufacturer Reason
for Recall		 At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified by letter on/about 05/16/2008. They were instructed to stop distributing the affected lots immediately and destroy any of the product they may have. A Product Disposition form was attached to be completed and returned via fax to Greiner bio-one. Consignees instructed to notify their customers and to provide Greiner bio-one with a list of their customers that have received the item. If you have any questions contact Manfred Abel at 704-261-7823.
Quantity in Commerce 1,606,005 units
Distribution Class II Recall - Nationwide Distribution.
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 = FMI and Original Applicant = GREINER MEDITECH, INC.
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