American Contract Systems, Inc. recalls IR Procedure Pack, CEAT19W; Medical convenience kit
- Recall date
- August 7, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3235-2024
- 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
IR Procedure Pack, CEAT19W; Medical convenience kit
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