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U.S. Department of Health and Human Services

Class 2 Device Recall PC Holdex

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 Class 2 Device Recall PC Holdexsee related information
Date Initiated by FirmAugust 05, 2008
Date PostedSeptember 30, 2008
Recall Status1 Terminated 3 on July 25, 2012
Recall NumberZ-2198-2008
Recall Event ID 49367
510(K)NumberK980768 
Product Classification Needle - Product Code FMI
ProductPlastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
Code Information Lot#: A030804
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110-7681
For Additional Information ContactManfred Pillichshammer
704-261-7800
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		Process design
ActionConsignees were notified by letter on 08/06/2008. Letters to Distributors instructed them to stop distribution of the affected product immediately and to hold any product of the lots they may have pending returned to Greiner bio-one. The were instructed to provide Greiner bio-one with a list of their customers who may have received the affected lot so that they can contact them. A Product Disposition form was included to be completed and returned to Greiner bio-one. Contact Greiner Bio-One North America, Inc. at 1-888-286-3883 for assistance.
Quantity in Commerce150,000 pcs
DistributionAL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV.
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 = FMI
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