American Contract Systems recalls Sterile Custom Packs to be used in surgical procedures.
- Recall date
- April 13, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2176-2020
- FDA classification
- Class II
- Brand / firm
- American Contract Systems
- Sold / distributed
- US Nationwide distribution including in the state of Pennsylvania.
Why it was recalled
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sterile Custom Packs to be used in surgical procedures.
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