Z-0531-2025 Class II Ongoing
FDA device recall Z-0531-2025 was initiated by Boston Scientific Corporation on October 28, 2024 and is designated Class II. Reason for recall: Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) The recall status is ongoing. Affected quantity: 52 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- October 28, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 units
Product Description
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Reason for Recall
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.
Code Information
UPN Number: 72400024. GTIN Number: 00878953000626. Lot Numbers: 32500739, 32500821, 32500820. Serial Numbers: 1100366088, 1100366115, 1100366089, 1100366116, 1100366090, 1100366117, 1100366091, 1100366118, 1100366092, 1100366119, 1100366093, 1100366120, 1100366094, 1100366121, 1100366095, 1100366122, 1100366096, 1100366123, 1100366097, 1100366144, 1100366098, 1100366145, 1100366099, 1100366146, 1100366100, 1100366147, 1100366101, 1100366148, 1100366102, 1100366149, 1100366103, 1100366150, 1100366104, 1100366151, 1100366105, 1100366152, 1100366106, 1100366153, 1100366107, 1100366154, 1100366108, 1100366155, 1100366109, 1100366156, 1100366110, 1100366157, 1100366111, 1100366158, 1100366112, 1100366159, 1100366113, 1100366160, 1100366114. Expiration Date: 09/23/2028