Boston Scientific Corporation recalls AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
- Recall date
- July 19, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2442-2019
- FDA classification
- Class II
- Brand / firm
- Boston Scientific Corporation
- Sold / distributed
- MN
Why it was recalled
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
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