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U.S. Department of Health and Human Services

Class 2 Device Recall AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff

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  Class 2 Device Recall AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff see related information
Date Initiated by Firm July 19, 2019
Create Date August 30, 2019
Recall Status1 Terminated 3 on April 23, 2020
Recall Number Z-2442-2019
Recall Event ID 83567
PMA Number P000053 
Product Classification Device, incontinence, mechanical/hydraulic - Product Code EZY
Product AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm
Part Number: 72400161
Code Information Lot Number: 23973023
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer 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 2		 Error in labeling
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
Quantity in Commerce 1 unit
Distribution MN
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = EZY and Original Applicant = Boston Scientific Corp.
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