Titan Touch Infr Zero Ang 18cm recall
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
Why was Titan Touch Infr Zero Ang 18cm recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 05708932539128, Lot Numbers: 8849582, 8849603, 8904185
- Product
- Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Recalling firm
- Coloplast Manufacturing US, LLC
- Quantity
- 15 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
- Recall date
- April 19, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)