Recall Z-0176-2012 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients.
| Date | Nov 8, 2011 (initiated Feb 11, 2011) |
| Status | Terminated |
| Reason | BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive. |
| Root cause | Device Design |
| Action | A Becton Dickinson Sales Consultant conducted a "on-site" visit to the single Customer account, Florida Hospital, on February 11, 2011. All units were successfully recovered. All product recovered was quarantined and destroyed. Becton Dickinson believes that all reasonable efforts to communicate the issue to the affected consignee have been completed. If you have any questions or request additional information please do not hesitate to call (201) 847-5636. |
| Quantity | 10,800 units |
| Distribution | Distributed only to Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093972 | BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 Becton, Dickinson & CO, Jan 21, 2010 |