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Vaginal Delivery ASDV25B (American Contract Systems) – Humidity Issue (2024)

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.

Moderate

FDAAug 7, 2024Nationwide• American Contract Systems, Inc.

Neuro Vascular Kit (American Contract) - Humidity Control Failure (2024)

Moderate

FDAAug 7, 2024Nationwide• American Contract Systems, Inc.

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Vaginal Delivery ASDV25B (American Contract Systems) – Humidity Issue (2024)

Neuro Vascular Kit (American Contract) - Humidity Control Failure (2024)

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