Recall Z-1472-2022 ยท OGR Ear, Nose, And Throat Surgical Tray
MEDLINE INDUSTRIES, LP - SPT
Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
| Date | Jun 6, 2022 |
| Status | Open, Classified |
| Reason | Kits contain leaking bottles of isopropyl alcohol |
| Root cause | Under Investigation by firm |
| Action | The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations. |
| Quantity | 477 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.