Recall Z-2442-2019
Boston Scientific Corporation · initiated July 19, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Codes / lots: Lot Number: 23973023
Reason for recall
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
FDA-determined 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
Details
- Recall number
- Z-2442-2019
- Initiated
- July 19, 2019
- Terminated
- April 23, 2020
- Product code
- EZY – Device, Incontinence, Mechanical/Hydraulic
- Quantity
- 1 unit
- Distribution
- MN
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA