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U.S. Department of Health and Human Services

Class 2 Device Recall PC Holdex

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 Class 2 Recall
PC Holdex
see related information
Date Posted September 30, 2008
Recall Status1 Open
Recall Number Z-2198-2008
Recall Event ID 49367
Premarket Notification
510(K) Number
K980768 
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product Plastic 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, North Carolina 28110-7681
For Additional Information Contact Manfred 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
DESIGN: Process Design
Action Consignees 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 Commerce 150,000 pcs
Distribution AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = GREINER MEDITECH, INC.
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