Relay PRO recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers: 2204210015, 2208250004, 2208250003; UDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers: 2112210189; UDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers: 2208240053, 2208250164, 2208220204; UDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers: B220211367, B220129307, B220211163; UDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers: 2208220081; UDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers: 2210110060, 2202150279, 2202150279; UDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers: B220209262; UDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers: 2208240183; UDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers: 2202030119; UDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers: 2109150299; UDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers: 2202100029; UDI/DI 00843576150010, REF 28-M4-28-250-28U, Lot Numbers: 2202010127; UDI/DI 00843576100046, REF 28-M4-30-095-30S, Lot Numbers: B220228338; UDI/DI 00843576149632, REF 28-M4-30-095-30U, Lot Numbers: 2208240127, 2112140029, 2202070140; UDI/DI 00843576150126, REF 28-M4-30-155-26U, Lot Numbers: 2203080218; UDI/DI 00843576100176, REF 28-M4-30-155-30S, Lot Numbers: B220825157, B211229047, B220211164, B211228037; UDI/DI 00843576149762, REF 28-M4-30-155-30U, Lot Numbers: 2202100215, 2208240129; UDI/DI 00843576100633, REF 28-M4-30-200-26S, Lot Numbers: B220207438; UDI/DI 00843576100305, REF 28-M4-30-200-30S, Lot Numbers: B220118082; UDI/DI 00843576100732, REF 28-M4-30-250-26S, Lot Numbers: B220202152; UDI/DI 00843576150027, REF 28-M4-30-250-30U, Lot Numbers: 2202030116; UDI/DI 00843576100053, REF 28-M4-32-095-32S, Lot Numbers: B210910015; UDI/DI 00843576100541, REF 28-M4-32-155-28S, Lot Numbers: B220301231; UDI/DI 00843576100183, REF 28-M4-32-155-32S, Lot Numbers: B220216239; UDI/DI 00843576149779, REF 28-M4-32-155-32U, Lot Numbers: 2202100265, 2202110370; UDI/DI 00843576100640, REF 28-M4-32-200-28S, Lot Numbers: B210626308, B210626307; UDI/DI 00843576100749, REF 28-M4-32-250-28S, Lot Numbers: B211222146; UDI/DI 00843576150331, REF 28-M4-32-250-28U, Lot Numbers: 2110120002; UDI/DI 00843576150034, REF 28-M4-32-250-32U, Lot Numbers: 2112180035; UDI/DI 00843576149656, REF 28-M4-34-100-34U, Lot Numbers: 2112110191, 2202120100, 2208230097; UDI/DI 00843576100558, REF 28-M4-34-145-30S, Lot Numbers: B210609033; UDI/DI 00843576150140, REF 28-M4-34-145-30U, Lot Numbers: 2210110037; UDI/DI 00843576100190, REF 28-M4-34-145-34S, Lot Numbers: B220210184, B211012027, B220210028, B220216053, B220216053, B220209191; UDI/DI 00843576149786, REF 28-M4-34-145-34U, Lot Numbers: 2110120028, 2109150326, 2109140012, 2110120025, 2208240141, 2208240140, 2208240126, 2208240029, 2208240030, 2208250006, 2208250005, 2112280069, 2201280546, 2202080066; UDI/DI 00843576100657, REF 28-M4-34-200-30S, Lot Numbers: B210430260, B220217323, B220216055, B220217319, B211222145, B220216055, B210430262, B220216054; UDI/DI 00843576150249, REF 28-M4-34-200-30U, Lot Numbers: 2202260090; UDI/DI 00843576100329, REF 28-M4-34-200-34S, Lot Numbers: B210428257, B211014252; UDI/DI 00843576149915, REF 28-M4-34-200-34U, Lot Numbers: 2202170286, 2202170286, 2202170219, 2202170278, 2202160200, 2202160200; UDI/DI 00843576100756, REF 28-M4-34-250-30S, Lot Numbers: B211221199; UDI/DI 00843576100077, REF 28-M4-36-100-36S, Lot Numbers: B220217276, B220217276; UDI/DI 00843576100206, REF 28-M4-36-145-36S, Lot Numbers: B221025248; UDI/DI 00843576100664, REF 28-M4-36-190-32S, Lot Numbers: B210622126, B221025300; UDI/DI 00843576100763, REF 28-M4-36-250-32S, Lot Numbers: B221007313; UDI/DI 00843576150058, REF 28-M4-36-250-36U, Lot Numbers: 2210110276, 2210100191; UDI/DI 00843576100084, REF 28-M4-38-100-38S, Lot Numbers: B220824128; UDI/DI 00843576150164, REF 28-M4-38-145-34U, Lot Numbers: 2202170235; UDI/DI 00843576100213, REF 28-M4-38-145-38S, Lot Numbers: B221026208; UDI/DI 00843576100671, REF 28-M4-38-190-34S, Lot Numbers: B220121067, B220317294; UDI/DI 00843576150263, REF 28-M4-38-190-34U, Lot Numbers: 2204140072; UDI/DI 00843576100473, REF 28-M4-38-250-38S, Lot Numbers: B220825007; UDI/DI 00843576100091, REF 28-M4-40-105-40S, Lot Numbers: B220216195, B220216195, B220125193; UDI/DI 00843576149687, REF 28-M4-40-105-40U, Lot Numbers: 2202160194; UDI/DI 00843576100589, REF 28-M4-40-145-36S, Lot Numbers: B220825008; UDI/DI 00843576100350, REF 28-M4-40-195-40S, Lot Numbers: B220222125, B220222125, B220216224, B220223318, B220223318, B220216224; UDI/DI 00843576100787, REF 28-M4-40-250-36S, Lot Numbers: B221025298; UDI/DI 00843576150379, REF 28-M4-40-250-36U, Lot Numbers: 2203010243; UDI/DI 00843576149694, REF 28-M4-42-105-42U, Lot Numbers: 2109100260; UDI/DI 00843576100596, REF 28-M4-42-150-38S, Lot Numbers: B220115098; UDI/DI 00843576100695, REF 28-M4-42-195-38S, Lot Numbers: B220420138; UDI/DI 00843576149700, REF 28-M4-44-105-44U, Lot Numbers: 2201170430; UDI/DI 00843576100602, REF 28-M4-44-155-40S, Lot Numbers: B220117359; UDI/DI 00843576100701, REF 28-M4-44-200-40S, Lot Numbers: B220121070; UDI/DI 00843576100374, REF 28-M4-44-200-44S, Lot Numbers: B220824149, B211229052, B220115095; UDI/DI 00843576150393, REF 28-M4-44-250-40U, Lot Numbers: 2201170418; UDI/DI 00843576150096, REF 28-M4-44-250-44U, Lot Numbers: 2112130139; UDI/DI 00843576100121, REF 28-M4-46-105-46S, Lot Numbers: B211203109; UDI/DI 00843576149717, REF 28-M4-46-105-46U, Lot Numbers: 2203030290; UDI/DI 00843576100718, REF 28-M4-46-200-42S, Lot Numbers: B220825037; UDI/DI 00843576100381, REF 28-M4-46-200-46S, Lot Numbers: B220825038; UDI/DI 00843576149977, REF 28-M4-46-200-46U, Lot Numbers: 2204200130; UDI/DI 00843576100510, REF 28-M4-46-250-46S, Lot Numbers: B210525287.

Product

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX

Recalling firm

Bolton Medical Inc.

Quantity

129 units

Distribution

Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.

Recall date

January 25, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)