FDAFDA · Food and drugs·Recall number Z-1360-2023
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Published April 19, 2023 · Recall initiated: March 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Coloplast Manufacturing US, LLC
- Distributor
- Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
- Lot
- UDI/DI 05708932319621, Lot Numbers: 8904177, 8849617
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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