Open Shoulder, LWOS39L; Medical convenience kit
FDA Recall Z-3230-2024 · Posted 2024-09-24
Recalling FirmAmerican Contract Systems, Inc.
Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2024-08-07
Product Quantity12 units
Reason for Recall
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.
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 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."
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.