Coloplast Manufacturing US, LLC 2023-04-19 Health serious FDA
Health · FDA · Recall #FDA-Z-1360-2023
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis Recall
Issued April 19, 2023 · Coloplast Manufacturing US, LLC
In April 2023, Coloplast Manufacturing US, LLC recalled the Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Coloplast Manufacturing US, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Coloplast Manufacturing US, LLC
- Category
- Health
- Recall date
- April 19, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
- Recall number
- FDA-Z-1360-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Coloplast Manufacturing US, LLC has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.