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FDA (Device enforcement)Recalled 2024-09-09class ii

Atrium Medical Corporation: iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Hazard

There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

Details from the source

Reason for recall: There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. Distribution: US Nationwide distribution in the states of FL, MA, MI, OH, WA. Quantity: 11 devices Lot/code info: UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042

UPC codes

00650862426168

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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