Recall Z-2198-2008 ยท FMI Needle, Hypodermic, Single Lumen
Greiner Bio-One North America, Inc.
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.
| Date | Sep 30, 2008 (initiated Aug 5, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 150,000 pcs |
| Distribution | AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980768 | VACUETTE HOLDEX Greiner Meditech, Inc., Apr 9, 1998 |