FDA-Device2019-09-11Class II
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Hazard
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Sold states
MN
Affected count
1 unit
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2442-2019More Boston Scientific Corporation recalls
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