Recall Z-3242-2024 ยท OGR Ear, Nose, And Throat Surgical Tray
American Contract Systems, Inc.
Nasal Sinus Pack, MTSN26B; Medical convenience kit
| Date | Sep 24, 2024 (initiated Aug 7, 2024) |
| Status | Open, Classified |
| Reason | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Root cause | Under Investigation by firm |
| Action | Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " -Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the |
| Quantity | 57 units |
| Distribution | US Nationwide distribution in the states of MO, MN, MA, OH, NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.