Recall Z-0756-2013 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
| Date | Nov 12, 2012 |
| Status | Terminated |
| Reason | BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints. |
| Root cause | Material/Component Contamination |
| Action | BD sent "ATTENTION: PRODUCT RECALL" letters dated November 12, 2012 via UPS to distributors and customers instructing them to examine their inventory immediately and discontinue the shipment of the affected product. All customers were instructed to return all products from the lot affected, by following the instructions on the enclosed packing slip,and BD will send them replacement products at no charge. Contact the firm at 10201-847-4267 for assistance. |
| Quantity | 2,944,700 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013971 | BD VACUTAINER SAFETY COAGULATION TUBE Becton, Dickinson & CO, Feb 1, 2002 |