Class II Recall

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

Summary

The FDA issued a Class II for RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX by Bolton Medical Inc.. Reason: The product may be shorter than packaging indicates.

Details

Source

Device Recall

External ID

Z-0997-2023

Action Date

2023-01-25

Status

Ongoing

Product Description

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

Lot/Code Info: 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.

Quantity Affected: 129 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-12-20

Company

Bolton Medical Inc.

Sunrise, FL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Bolton Medical Inc. has 5 FDA actions in our database, including 5 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bolton Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Bolton Medical Inc. have FDA actions?

Bolton Medical Inc. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0997-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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