Recall Z-0846-2019 ยท JOL Catheter And Tip, Suction
Teleflex Medical
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
| Date | Jan 7, 2019 |
| Status | Terminated |
| Reason | The internal tip is missing from the device, causing the device to not function as intended. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall by letter on 01/07/2019. The firm requested the return of the units. |
| Quantity | 80 units |
| Distribution | TX, NY, DC and Philippines |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.