Recall Z-1746-2017 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for
| Date | Apr 6, 2017 (initiated Mar 16, 2017) |
| Status | Terminated |
| Reason | BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection. |
| Root cause | Nonconforming Material/Component |
| Action | BD sent an "Urgent Product Correction Letters and Customer Product Correction Response Forms" dated March 16, 2017 via email or UPS to their customers and distributors. |
| Quantity | 13,064,500 tubes (non-expired) |
| Distribution | Worldwide - US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945952 | VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic, Jan 18, 1995 |