Recall Z-2442-2019— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2019-07-19, terminated 2020-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161. Reason: Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore...
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-19
- Terminated
- 2020-04-23
- Firm location
- Marlborough, MA, United States
Product description
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..
Data sourced from openFDA. This site is unofficial and independent of the FDA.