Exact Medical Manufacturing, Inc. recalls Hays Ultrasound kit Item ID: H1000SE
- Recall date
- April 29, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1918-2021
- FDA classification
- Class II
- Brand / firm
- Exact Medical Manufacturing, Inc.
- Sold / distributed
- US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Why it was recalled
No 510k for the product to be used in a natural or surgical opening to the body
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Hays Ultrasound kit Item ID: H1000SE
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