FDAClass IISeptember 11, 2019

AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff recall

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

Why was AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 23973023

Product
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Recalling firm
Boston Scientific Corporation
Quantity
1 unit
Distribution
MN
Recall date
September 11, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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