Sharp Medical Products recalls SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
- Recall date
- February 8, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1366-2021
- FDA classification
- Class II
- Brand / firm
- Sharp Medical Products
- Sold / distributed
- U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None
Why it was recalled
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
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