Shoulder Medical Kit (American Contract) - Humidity Control Failure (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Shoulder, SESH18I; Medical convenience kit
Brand
American Contract Systems, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00191072198532, Lot: 2405112, Exp: 05/11/2025
Products Sold
UDI-DI: 00191072198532; Lot: 2405112; Exp: 05/11/2025
American Contract Systems, Inc. is recalling Shoulder, SESH18I; Medical convenience kit due to ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026