FDA recall Z-2442-2019
Boston Scientific Corporation · Class II · device
Product
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Reason for recall
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Distribution
MN
Key facts
- Status
- Terminated
- Initiation date
- 2019-07-19
- Report date
- 2019-09-11
- Termination date
- 2020-04-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Marlborough, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2442-2019