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U.S. Department of Health and Human Services

Class 2 Device Recall Coloplast

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  Class 2 Device Recall Coloplast see related information
Date Initiated by Firm March 01, 2023
Date Posted April 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-1361-2023
Recall Event ID 91800
PMA Number P000006 
Product Classification Device, impotence, mechanical/hydraulic - Product Code FHW
Product Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
Code Information UDI/DI 05708932072519, Lot Numbers: 8887609
Recalling Firm/
Manufacturer		 Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information Contact Coloplast Customer Service
800-258-3476
Manufacturer Reason
for Recall		 A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
FDA Determined
Cause 2		 Process change control
Action The firm issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice on 03/01/2023 by UPS next day air. The notice explained the issue and the hazard to health. The notice requests the removal and return of the affected product. Distributors are instructed to notify their customers. For further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email urology@coloplast.com.
Quantity in Commerce 0
Distribution Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = FHW and Original Applicant = COLOPLAST CORP.
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