Class II

Medical Device Recall: Day Surgery General Pack, FHGE18T; 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

280 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3231-2024

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.