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Boston Scientific Corporation Recall 95608

Description: AMS Artificial Urinary Sphincter Control Pump

Boston Scientific Corporation Recall 95608 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0530-2025
Event ID95608
Event DescriptionAMS Artificial Urinary Sphincter Control Pump
Product TypeDevices
DistributionWorldwide - 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.
Quantity16 units
Recall ReasonPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Device Classification20241204
Device Code InfoUPN 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 Date20241125
Recall Initiation Date20241028
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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