Exact Medical Manufacturing product recalled over sterility concerns
- Recall date
- April 29, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Exact Medical Manufacturing, Inc. recalls Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
- Recall number
- Z-1907-2021
- 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
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
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