Exact Medical Manufacturing, Inc. recalls Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
- Recall date
- April 29, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1915-2021
- 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
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
Get recall alerts
Free email alert whenever Exact Medical Manufacturing, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Exact Medical Manufacturing, Inc.