Recall Z-2434-2015 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
| Date | Aug 20, 2015 (initiated Jun 23, 2015) |
| Status | Terminated |
| Reason | Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time. |
| Root cause | Process control |
| Action | Becton Dickinson notified their affected customers of this recall by sending them an Urgent Product Recall Letter dated June 23, 2015 via UPS 2nd Day. |
| Quantity | 238, 000 (Lot #5133959) and 243,000 (Lot #5133957) |
| Distribution | Distributed in FL, IL, MA, MI, MO, PA and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| BK050036 | Not in our 510(k) copy |