| Class 2 Device Recall Bolton Medical |  |
Date Initiated by Firm | December 20, 2022 |
Date Posted | January 19, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0997-2023 |
Recall Event ID |
91292 |
Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
|
Product | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX |
Code Information |
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.
|
Recalling Firm/ Manufacturer |
Bolton Medical Inc. 799 International Pkwy Sunrise FL 33325-6220
|
For Additional Information Contact | Megan Indeglia 954-626-5122 |
Manufacturer Reason for Recall | The product may be shorter than packaging indicates |
FDA Determined Cause 2 | Labeling Change Control |
Action | On 12/15/2022, Terumo Aortic/Bolton Medical, Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees by mail. The notice explained the problem and the risk, and requested the return of the device to a Terumo Sales Representative. |
Quantity in Commerce | 129 units |
Distribution | Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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