Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 05708932319621, Lot Numbers: 8904177, 8849617
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Coloplast Manufacturing US, LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Product Codes/Lot Numbers:
UDI/DI 05708932319621, Lot Numbers: 8904177, 8849617
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1360-2023
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