Recall Z-1297-2018 ยท KDD Kit, Surgical Instrument, Disposable
Arrow International Inc
Large Volume Abdominal Paracentesis Kit
| Date | Oct 24, 2017 |
| Status | Terminated |
| Reason | Product packaging may not be completely sealed. |
| Root cause | Component design/selection |
| Action | On October 24, 2017 and Urgent Medical Device Recall letter was issued to customers to review inventory and if there's any affected stock, to immediately discontinue use, quarantine and prepare to return to recalling firm. Questions or concerns can be directed to 1-855-419-8507 or 1-866-246-6990 |
| Quantity | 30,577 eaches |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874063 | ENTERON ABDOMINAL PARACENTESIS TRAY Endovations, Dec 4, 1987 |