Recall Z-0816-2011 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) Becton Dickinson & Co., Franklin Lakes, NJ, USA Intended use: Blood collection
| Date | Dec 27, 2010 (initiated Oct 5, 2010) |
| Status | Terminated |
| Reason | There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub. |
| Root cause | Process control |
| Action | BD Diagnostics sent "RECALL NOTIFICATION" separate letters October 1 and 5, 2010 and follow up letter dated October 8, 2010, as well as a letter dated December 1, 2010 to all distributors and customers commencing October 5, 2010 by federal express. The letters describe the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory for specific catalog and lot numbers, and return product from the lots following the instructions on the enclosed packing slip (BD will send replacement upon receipt of returned product). If |
| Quantity | 4,223,200 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011984 | BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET Becton, Dickinson & CO, Aug 29, 2001 |