Recall Z-1531-2018 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x x 12 (Catalog no 367342)
| Date | Mar 20, 2018 |
| Status | Terminated |
| Reason | Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. |
| Root cause | Material/Component Contamination |
| Action | Immediately review your inventory for the specific Catalog (Ref) and lot numbers, and quarantine product subject to the recall. Immediately discontinue the distribution of the affected product. If you have inventory of the recalled product, please complete the attached Business Response Form and return the recalled product following the enclosed packing instruction. This is required so that BD may process your product replacement. If you do not have the recalled product, please complete the attached Business Response Form as well so that BD receives an acknowledgement of your receipt of thi |
| Distribution | US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030573 | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 Bd Vacutainer Systems Preanalyical Solutions, May 8, 2003 |