AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
This recall has been terminated (originally issued July 19, 2019).
- Company
- Boston Scientific Corporation
- Recall Initiated
- July 19, 2019
- Terminated
- April 23, 2020
- Recall Number
- Z-2442-2019
- Quantity
- 1 unit
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Distribution
MN
Lot / Code Info
Lot Number: 23973023
Root Cause
Error in labeling
Action Taken
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
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