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FDA (Device enforcement)Recalled 2022-12-20class ii

Bolton Medical Inc.: RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

Hazard

The product may be shorter than packaging indicates

Details from the source

Reason for recall: The product may be shorter than packaging indicates Distribution: Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China. Quantity: 640 units Lot/code info: UDIUDI/DI 00843576100954, REF 28-N4-22-159-22S, Lot Numbers: B210719245, B210619174; UDI/DI 00843576100831, REF 28-N4-24-099-24S, Lot Numbers: B220323028, B211222140; UDI/DI 00843576150423, REF 28-N4-24-099-24U, Lot Numbers: 2204210157, 2204210158, 2208230256, 2208250035; UDI/DI 00843576100961, REF 28-N4-24-159-24S, Lot Numbers: B220104035, B220824113, B210612293, B220201173; UDI/DI 00843576150553, REF 28-N4-24-159-24U, Lot Numbers: 2202090215, 2202090293; UDI/DI 00843576101227, REF 28-N4-24-259-24S, Lot Numbers: B220210257, B220210257; UDI/DI 00843576150812, REF 28-N4-24-259-24U, Lot Numbers: 2210110048, 2210110049, 2210100193; UDI/DI 00843576100848, REF 28-N4-26-104-26S, Lot Numbers: B220226088, B220414055; UDI/DI 00843576150430, REF 28-N4-26-104-26U, Lot Numbers: 2110070047, 2202020135, 2202010164, 2112210201, 2202120154, 2202260085, 2204140202; UDI/DI 00843576100978, REF 28-N4-26-164-26S, Lot Numbers: B220316171, B210927313, B210602367, B220303176, B220316275, B220204220, B220210181, B220210141, B211215127, B220203121; UDI/DI 00843576150560, REF 28-N4-26-164-26U, Lot Numbers: 2110130276, 2203030136, 2203040029, 2206140190, 2202280430, 2203030197, 2202020185, 2202090218, 2202100235; UDI/DI 00843576150690, REF 28-N4-26-204-26U, Lot Numbers: 2201150114, 2204150063, 2206130239; UDI/DI 00843576100855, REF 28-N4-28-104-28S, Lot Numbers: B220323030, B220323295, B221024139, B221026118, B221024275; UDI/DI 00843576150447, REF 28-N4-28-104-28U, Lot Numbers: 2108090034, 2206140194, 2

UPC codes

00843576100954, 00843576100831, 00843576150423, 00843576100961, 00843576150553, 00843576101227, 00843576150812, 00843576100848, 00843576150430, 00843576100978, 00843576150560, 00843576150690, 00843576100855, 00843576150447, 00843576150935, 00843576100985, 00843576150577, 00843576101449, 00843576151031, 00843576101111, 00843576150706, 00843576100862, 00843576150454, 00843576101357, 00843576150942, 00843576100992, 00843576150584, 00843576101456, 00843576151048, 00843576101128, 00843576150713, 00843576101258, 00843576100879, 00843576150461, 00843576101364, 00843576150959, 00843576101005, 00843576150591, 00843576101463, 00843576151055

Source

Official record: FDA (Device enforcement)

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

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