Recall Z-0567-2016 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube.
| Date | Dec 31, 2015 (initiated Dec 3, 2015) |
| Status | Terminated |
| Reason | Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment. |
| Root cause | Process change control |
| Action | The firm, BD, issued an "URGENT PRODUCT RECALL" notifications/Recall Response Forms to their customers dated 12/3/2015 via email and/or UPS 2nd Day Mail. The notification identified the reason for the recall; how to identify affected product; and actions to be taken. The customers were instructed customers to immediately review their inventory; complete the enclosed Recall Response Form and fax (1-866-873-0312 it to BD or email it to bd4964@stericycle.com; and return all affected products with the completed Recall Response Form following instructions on the enclosed packing instruction, even |
| Quantity | 29,815,600 units in total |
| Distribution | Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of 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 |