medical Class II Updated 2024-12-04

Boston Scientific Corporation recalls AMS Artificial Urinary Sphincter Control Pump

Recalled Product

AMS Artificial Urinary Sphincter Control Pump


Hazard / Issue

Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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
View official government recall

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