Boston Scientific Corporation Recall 95608
Description: AMS Artificial Urinary Sphincter Control Pump
Boston Scientific Corporation Recall 95608 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0530-2025 |
Event ID | 95608 |
Event Description | AMS Artificial Urinary Sphincter Control Pump |
Product Type | Devices |
Distribution | 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. |
Quantity | 16 units |
Recall Reason | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) |
Device Classification | 20241204 |
Device Code Info | UPN Number: 72400098. GTIN Number: 00878953000688. Lot Number: 32487464. Serial Numbers: 1100366307, 1100366316, 1100366309, 1100366317, 1100366310, 1100366319, 1100366311, 1100366320, 1100366312, 1100366321, 1100366313, 1100366323, 1100366314, 1100366324, 1100366315, 1100366325. Expiration Date: 09/24/2028 |
Center Classification Date | 20241125 |
Recall Initiation Date | 20241028 |
Recalling Firm | Boston Scientific Corporation |
Initial Notification | Letter |
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