Recall Z-0777-2007 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile.
| Date | May 10, 2007 (initiated Mar 20, 2007) |
| Status | Terminated |
| Reason | The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube. |
| Root cause | Other |
| Action | Recall letters were sent to customers on 3/11/2007 via a third party, West Inc., Appleton, WI who will coordinate the mailing to all consignees. |
| Quantity | 147,200 units |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980414 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET Bd Becton Dickinson Vacutainer Systems Preanalytic, Mar 3, 1998 |