Recall Z-1690-2016 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson & Company
1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer catalog number 381720
| Date | May 18, 2016 (initiated Mar 18, 2016) |
| Status | Terminated |
| Reason | The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage. |
| Root cause | Device Design |
| Action | BD isssued an urgent voluntary product recall lettter/recall response card on 3/18/2016. |
| Quantity | 1,305,150 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.