Recall Z-1189-2017 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 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 clinical
| Date | Jan 16, 2017 |
| Status | Terminated |
| Reason | A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant. |
| Root cause | Process control |
| Action | BD sent an Urgent Product Recall letter dated January 16, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Recall Response Form and fax the completed form back to BD at 1-844-388-5534 or email the completed form to bd8872@stericycle.com. For questions call 1-844-265-7408. |
| Quantity | 1,488,800 tubes |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia |
| 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 |