Class II

Medical Device Recall: Vaginal Delivery, ASDV25B; Medical convenience kit

American Contract Systems, Inc. · August 7, 2024

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.

Distribution

US Nationwide distribution in the states of MO, MN, MA, OH, NE.

States Affected

NATIONWIDE

Quantity Affected

1 unit

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3238-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.