Recall Z-0456-2016 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristi
| Date | Dec 21, 2015 (initiated Nov 17, 2015) |
| Status | Terminated |
| Reason | Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying. |
| Root cause | Under Investigation by firm |
| Action | BD sent an "Urgent Product Recall notifications/Recall Response Forms dated November 17, 2015 via email and/or UPS Next Day Mail on November 17, 2015 to their customers. The notification identifies the affected product and problem and actions to be taken. Customers are requested to take the following actions (1) Immediately review their inventory and quarantine the product subject to the recall and immediately discontinue the shipment of the affected product (2) complete the enclosed Recall Response Firm and fax it bat to BD at 1.866.873.0312 or emai to bd8554@stericycle.com (3) Return all a |
| Quantity | 4,835,000 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981013 | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE Becton Dickinson Vacutainer Systems, Jun 17, 1998 |