ENT, COEN27N; Medical convenience kit
Recall
- Recall Number
- Z-3241-2024
- Event Number
- 95261
- Firm
- American Contract Systems, Inc.
- FEI Number
- 3003419114
- Product Code
- OGR
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 7, 2024
- Posted
- September 24, 2024
- Address
- 2610 Ne Industrial Dr, Ste 220, Kansas City, MO, 64117-2648
Description
ENT, COEN27N; Medical convenience kit
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.
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 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. - Discard all affected kits and document on the enclosed Response Form."
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
66 units