Recall Z-0034-2007 ยท JAK System, X-Ray, Tomography, Computed
Becton Dickinson & Company
BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm ----- REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm
| Date | Oct 12, 2006 (initiated Aug 11, 2006) |
| Status | Terminated |
| Reason | A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity. |
| Root cause | Other |
| Action | Recall notification were mailed out first class mail, return receipt requested, approximately 8/24/2006 to distributors, who were then asked to contact their customers. |
| Quantity | 110,300 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011984 | BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET Becton, Dickinson & CO, Aug 29, 2001 |