Recalls / —
—#175750
Product
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
- FDA product code
- EZY — Device, Incontinence, Mechanical/Hydraulic
- Device class
- Class 3
- Medical specialty
- Gastroenterology, Urology
- PMA numbers
- P000053
- Affected lot / code info
- Lot Number: 23973023
Why it was recalled
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Root cause (FDA determination)
Error in labeling
Action the firm took
Boston Scientific contacted customer via the sales representative on July 19, 2019. The removal letter was given to the customer by the sales representative. The letter states reason for recall, health risk and Immediately segregate the affected product to ensure that it will not be used. 2. Contact the Boston Scientific Field Action center for an RGA number to facilitate product return. 3. Ship product back to Boston Scientific
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291
Distribution
- Distribution pattern
- MN
Timeline
- Recall initiated
- 2019-07-19
- Terminated
- 2020-04-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #175750. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.