medical Class II Updated 2024-10-02

American Contract Systems, Inc. recalls Shoulder, SESH18I; Medical convenience kit

Recalled Product

Shoulder, SESH18I; Medical convenience kit


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00191072198532; Lot: 2405112; Exp: 05/11/2025
View official government recall

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