American Contract Systems, Inc. recalls Hand Pack, AKHD97C; Medical convenience kit

Recall date

August 7, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3237-2024

FDA classification

Class II

Brand / firm

American Contract Systems, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hand Pack, AKHD97C; Medical convenience kit