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.
FDA Recall Z-2198-2008 · Posted 2008-09-30
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Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2008-08-05
Date Terminated2012-07-25
Product Quantity150,000 pcs
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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