Coloplast Manufacturing US, LLC Recall 91800
Description: Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Coloplast Manufacturing US, LLC Recall 91800 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1360-2023 |
| Event ID | 91800 |
| Event Description | Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. |
| Quantity | 9 units |
| Recall Reason | 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. |
| Device Classification | 20230419 |
| Device Code Info | UDI/DI 05708932319621, Lot Numbers: 8904177, 8849617 |
| Center Classification Date | 20230412 |
| Recall Initiation Date | 20230301 |
| Recalling Firm | Coloplast Manufacturing US, LLC |
| Initial Notification | Letter |
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