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Terminated

AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161

FDA Recall Z-2442-2019 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeEZY
Date Initiated2019-07-19
Date Terminated2020-04-23
Product Quantity1 unit

Reason for Recall

Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..

Firm Action

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

Root Cause

Error in labeling

Distribution Pattern

MN

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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