| |
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-0998-2023 |
| Recall Event ID |
91292 |
| Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
|
| Product |
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX |
| Code Information |
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, 2112170035, 2202100079, 2202110166, 2202160141;
UDI/DI 00843576150935, REF 28-N4-28-164-24U, Lot Numbers: 2202160143, 2202160143, 220614019;
UDI/DI 00843576100985, REF 28-N4-28-164-28S, Lot Numbers: 2202150157, B210713325, B211019291, B211218042, B211217126, B211228051, B211228183, B211019294, B220302187, B220308234, B220308196, B220315291, B220315290, B220316085, B220224046, B211215130, B220211180, B220215104, B220215116, B211218039, B220215116;
UDI/DI 00843576150577, REF 28-N4-28-164-28U, Lot Numbers: 2202140139, 2203160088, 2203110300, 2208190099, 2203110300, 2208230038;
UDI/DI 00843576101449, REF 28-N4-28-204-24S, Lot Numbers: B220216144;
UDI/DI 00843576151031, REF 28-N4-28-204-24U, Lot Numbers: 2203040078, 2203040076;
UDI/DI 00843576101111, REF 28-N4-28-204-28S, Lot Numbers: B220222108, B220222103, B220222101, B220216186, B220315302;
UDI/DI 00843576150706, REF 28-N4-28-204-28U, Lot Numbers: 2203140261, 2210260120;
UDI/DI 00843576100862, REF 28-N4-30-104-30S, Lot Numbers: B220222073, B220613221, B220316226,
UDI/DI 00843576150454, REF 28-N4-30-104-30U, Lot Numbers: 2202150087, 2108110152, 2108110159, 2108140005, 2108110132, 2202160183, 2202150087, 2202280426, 2110180211, 2206130118, 2206130220, 2206130222, 2108240015;
UDI/DI 00843576101357, REF 28-N4-30-164-26S, Lot Numbers: B220316227, B220224140, B220224216, B220223287, B220224044, B220222297, B220225423;
UDI/DI 00843576150942, REF 28-N4-30-164-26U, Lot Numbers: 2203040072, 2110130019, 2110130017, 2203040073, 2110190312, 2208250041, 2112220164, 2201210010, 2202050219, 2202030151, 2210110302, 2205210093;
UDI/DI 00843576100992, REF 28-N4-30-164-30S, Lot Numbers: B220324178, B220324178, B220324163, B211012014;
UDI/DI 00843576150584, REF 28-N4-30-164-30U, Lot Numbers: 2203010234, 2202230316, 2202250014, 2202280425, 2202180529, 2202220074, 2202220072, 2202220069, 2202180529, 2202220074, 2202220072, 2202220069, 2203020201, 2206130228, 2202140234;
UDI/DI 00843576101456, REF 28-N4-30-209-26S, Lot Numbers: B220316255;
UDI/DI 00843576151048, REF 28-N4-30-209-26U, Lot Numbers: 2112140027, 2112130022, 2202160146, 2202150163, 2202160145, 2203160257, 2208250012, 2201180076, 2203160257, 2208240034;
UDI/DI 00843576101128, REF 28-N4-30-209-30S, Lot Numbers: B220326008, B220222333;
UDI/DI 00843576150713, REF 28-N4-30-209-30U, Lot Numbers: 2203160252, 2202220110, 2202220113, 2203160253, 2112210090, 2201040111, 2201180074, 2202140257, 2202100239, 2202110347;
UDI/DI 00843576101258, REF 28-N4-30-259-30S, Lot Numbers: B220215153;
UDI/DI 00843576100879, REF 28-N4-32-104-32S, Lot Numbers: B220216231, B221021262, B220324319;
UDI/DI 00843576150461, REF 28-N4-32-104-32U, Lot Numbers: 2108120046, 2107140315, 2202180555, 2202160240, 2202170062, 2107260368, 2107240008, 2112170233, 2202190002, 2202180531, 2202180555, 2202190002, 2107260364, 2112270017, 2202040221;
UDI/DI 00843576101364, REF 28-N4-32-164-28S, Lot Numbers: B220324327, B220822175, B220824051, B220823128, B220824185, B220824144, B211216067, B220325018, B220324175, B220324176, B220825153, B211215259, B220324175, B220324176, B220823156, B220823157;
UDI/DI 00843576150959, REF 28-N4-32-164-28U, Lot Numbers: 2203230306, 2210210006, 2210260127, 2202230291, 2202230295;
UDI/DI 00843576101005, REF 28-N4-32-164-32S, Lot Numbers: B220325138, B220323296, B220323298, B220613231, B211211183, B211214172, B211211162;
UDI/DI 00843576150591, REF 28-N4-32-164-32U, Lot Numbers: 2203250141, 2203230297, 2110060132, 2203030284, 2208240048, 2208250009, 2210250032, 2203080200, 2112110095, 2204010186, 2210250296;
UDI/DI 00843576101463, REF 28-N4-32-209-28S, Lot Numbers: B220323320;
UDI/DI 00843576151055, REF 28-N4-32-209-28U, Lot Numbers: 2202020166, 2202180572, 2112150321, 2112110166, 2112110165, 2202280418, 2205250253;
UDI/DI 00843576101135, REF 28-N4-32-209-32S, Lot Numbers: B220324197, B211214116, B220222117, B220222117;
UDI/DI 00843576150720, REF 28-N4-32-209-32U, Lot Numbers: 2203230299, 2204090207, 2112140173, 2208250166, 2208230272;
UDI/DI 00843576101562, REF 28-N4-32-259-28S, Lot Numbers: B211012003;
UDI/DI 00843576151154, REF 28-N4-32-259-28U, Lot Numbers: 2206130123;
UDI/DI 00843576150478, REF 28-N4-34-109-34U, Lot Numbers: 2203080004, 2203100247, 2108210088, 2109030355, 2203080007, 2112210087, 2112210085, 2210110299, 2112110082, 2203080003, 2206130241;
UDI/DI 00843576101371, REF 28-N4-34-154-30S, Lot Numbers: B210608025, B211213134, B211214113, B211028048, B211101323, B211220050, B211221096, B220314244;
UDI/DI 00843576150966, REF 28-N4-34-154-30U, Lot Numbers: 2203040077, 2203040075, 2204040345, 2110040246, 2202240217, 2204120411, 2112180054, 2112200048, 2210120224, 2202050011;
UDI/DI 00843576101012, REF 28-N4-34-154-34S, Lot Numbers: B211221131, B211220039, B210610038;
UDI/DI 00843576150607, REF 28-N4-34-154-34U, Lot Numbers: 2203080204, 2202220094, 2109070357, 2109040003, 2108280016, 2107300166, 2107300158, 2202220127, 2202220104, 2202220129, 2109040002, 2112200021, 2112210095, 2201070130, 2202260034, 2202220096, 2202220075, 2202220079, 2202220138, 2202220102, 2201070146, 2202220075, 2202220138, B220315087;
UDI/DI 00843576151062, REF 28-N4-34-209-30U, Lot Numbers: 2205250147, 2112200052, 2201190027, 2201180135, 2201310004;
UDI/DI 00843576101142, REF 28-N4-34-209-34S, Lot Numbers: B211214294, B220324009, B220324165, B220324181, B220326025, B220324181, B211214174, B220325013, B220329320;
UDI/DI 00843576150737, REF 28-N4-34-209-34U, Lot Numbers: 2210260199, 2210260201, 2210260198, 2210260200, 2210260126, 2210260197, 2210260207, 2203090075, 2203100243, 2203250143, 2206140097;
UDI/DI 00843576170155, REF 28-N4-34-210-44U, Lot Numbers: 2208240124;
UDI/DI 00843576101272, REF 28-N4-34-259-34S, Lot Numbers: B211222139;
UDI/DI 00843576150867, REF 28-N4-34-259-34U, Lot Numbers: 2210100114;
UDI/DI 00843576100893, REF 28-N4-36-109-36S, Lot Numbers: B211213218, B221007301, B211215203, B220226036, B220228230, B220228434, B220322215,
UDI/DI 00843576150485, REF 28-N4-36-109-36U, Lot Numbers: 2107150330, 2107210144, 2107150333, 2112160106;
UDI/DI 00843576101388, REF 28-N4-36-154-32S, Lot Numbers: B220825195, B220316259, B220822023, B211221094;
UDI/DI 00843576150973, REF 28-N4-36-154-32U, Lot Numbers: 2202140171, 2203100002, 2110060302, 2202170251, 2203080225, 2203080362, 2203030299, 2112100338, 2112150158, 2112150159, 2202150132, 2202140062, 2201200119, 2202140062;
UDI/DI 00843576150973, REF 28-N4-36-154-32U, Lot Numbers: 2202120091;
UDI/DI 00843576101029, REF 28-N4-36-154-36S, Lot Numbers: B220324164, B211217046, B220825165, B211217043, B220420031, B220415060, B220420032, B220419247;
UDI/DI 00843576150614, REF 28-N4-36-154-36U, Lot Numbers: 2202140142, 2202140222, 2202140142, 2202120084, 2108040300, 2108100279, 2110120294, 2202250085, 2204200029, 2204190245, 2204140198, 2204180291, 2201200081;
UDI/DI 00843576101487, REF 28-N4-36-199-32S, Lot Numbers: B220420141, B220824035, B220823266, B211217230, B220420142;
UDI/DI 00843576151079, REF 28-N4-36-199-32U, Lot Numbers: 2112140115, 2202160005, 2202160147, 2202150173, 2202160062, 2202160192, 2202190003, 2202220342, 2201180071, 2201210202, 2202150173, 2202160192, 2202190003, 2202160147, 2201310240;
UDI/DI 00843576101159, REF 28-N4-36-199-36S, Lot Numbers: B220325145, B220316278, B220614146, B220812095, B220824139;
UDI/DI 00843576150744, REF 28-N4-36-199-36U, Lot Numbers: 2202160190, 2202170035, 2203030285, 2203250159, 2204200134, 2203080251, 2203020257, 2203040068, 2203160254, 2203160313, 2112180048, 2112200054, 2112200042, 2202120166, 2204200137, 2204200132, 2202120166, 2202170035;
UDI/DI 00843576151178, REF 28-N4-36-259-32U, Lot Numbers: 2102240015, 2201170287;
UDI/DI 00843576101289, REF 28-N4-36-259-36S, Lot Numbers: B220412367, B220226086;
UDI/DI 00843576150492, REF 28-N4-38-109-38U, Lot Numbers: 2201290084, 2107220127, 2112010077, 2107220126;
UDI/DI 00843576101395, REF 28-N4-38-154-34S, Lot Numbers: B220329299, B220418293;
UDI/DI 00843576150980, REF 28-N4-38-154-34U, Lot Numbers: 2201210011, 2204210129, 2204060407, 2204220290, 2112130021, 2201290305;
UDI/DI 00843576101036, REF 28-N4-38-154-38S, Lot Numbers: B220329318, B220420115, B211215133, B211215143, B211215134, B211227031, B220823037;
UDI/DI 00843576150621, REF 28-N4-38-154-38U, Lot Numbers: 2110130259, 2201260405, 2110130263, 2110130261, 2110130262, 2204210143, 2208230039, 2208250172, 2201200092, 2201200099, 2201210068, 2201260344, 2205060274;
UDI/DI 00843576101494, REF 28-N4-38-199-34S, Lot Numbers: B220414211;
UDI/DI 00843576151086, REF 28-N4-38-199-34U, Lot Numbers: 2203030169, 2210260129, 2206130122, 2112220144, 2112150208, 2201180083, 2201180079, 2201180132, 2201210298;
UDI/DI 00843576101166, REF 28-N4-38-199-38S, Lot Numbers: B220411209, B220823257, B220614191, B220823260;
UDI/DI 00843576150751, REF 28-N4-38-199-38U, Lot Numbers: 2203080257, 2201210100, 2201210117, 2201210186, 2201210057, 2201270226, 2208230274, 2208230124, 2208240033, 2208230258, 2208220167, 2208250078, 2208240184, 2208250152, 2201210157, 2201250164;
UDI/DI 00843576101593, REF 28-N4-38-259-34S, Lot Numbers: B220315384;
UDI/DI 00843576151185, REF 28-N4-38-259-34U, Lot Numbers: 2108260329;
UDI/DI 00843576101296, REF 28-N4-38-259-38S, Lot Numbers: B210609044, B211214297, B220824031;
UDI/DI 00843576150881, REF 28-N4-38-259-38U, Lot Numbers: 2203080242, 2108040320, 2204110222, 2204200258;
UDI/DI 00843576100916, REF 28-N4-40-114-40S, Lot Numbers: B211220015;
UDI/DI 00843576101401, REF 28-N4-40-154-36S, Lot Numbers: B220212187, B211218056, B211221089, B220214225, B220328369;
UDI/DI 00843576150997, REF 28-N4-40-154-36U, Lot Numbers: 2203240199, 2203250146, 2201210024, 2201210021, 2201210027, 2201310002;
UDI/DI 00843576101043, REF 28-N4-40-154-40S, Lot Numbers: B220328261, B220329007, B220328341, B220124254, B211227044, B220301024;
UDI/DI 00843576150638, REF 28-N4-40-154-40U, Lot Numbers: 2201200112, 2205180204, 2204220151, 2204210111, 2204200034, 2204090201, 2201180080, 2201210330, 2203010010, 2204230122, 2201250163;
UDI/DI 00843576101500, REF 28-N4-40-204-36S, Lot Numbers: B220324328, B220316279;
UDI/DI 00843576151093, REF 28-N4-40-204-36U, Lot Numbers: 2112130223, 2210260205, 2204220084, 2201310010, 2201280055, 2204200217, 2204220085, 2204200140, 2210120145, 2210260204, 2201220095;
UDI/DI 00843576101173, REF 28-N4-40-204-40S, Lot Numbers: B220328304, B220328305, B220613305;
UDI/DI 00843576150768, REF 28-N4-40-204-40U, Lot Numbers: 2203030296, 2204200040, 2203080217, 2201150117, 2201220082, 2204210012, 2204210125, 2201220134, 2201280513, 2201270355, 2204200039;
UDI/DI 00843576101609, REF 28-N4-40-259-36S, Lot Numbers: B220824044, B220824036;
UDI/DI 00843576151192, REF 28-N4-40-259-36U, Lot Numbers: 2204200222;
UDI/DI 00843576150898, REF 28-N4-40-259-40U, Lot Numbers: 2204190260;
UDI/DI 00843576100923, REF 28-N4-42-114-42S, Lot Numbers: B220321140, B220404334;
UDI/DI 00843576150515, REF 28-N4-42-114-42U, Lot Numbers: 2203160312, 2204040417, 2203160251, 2203220286;
UDI/DI 00843576101418, REF 28-N4-42-159-38S, Lot Numbers: B211012054, B220325029, B211012055, B220321152, B211012056, B220328370, B220404378, B220402106;
UDI/DI 00843576101050, REF 28-N4-42-159-42S, Lot Numbers: B220316277, B220406080, B220402047, B211009014, B220414056, B220406068;
UDI/DI 00843576150645, REF 28-N4-42-159-42U, Lot Numbers: 2110140278, 2110140277, 2110140280, 2204210144, 2204210162, 2204210161, 2201310162, 2201310237, 2202010186, 2204210146, 2204200119;
UDI/DI 00843576151109, REF 28-N4-42-204-38U, Lot Numbers: 2108140131, B220322396, 2107280013;
UDI/DI 00843576100930, REF 28-N4-44-114-44S, Lot Numbers: B220222271, B220222274;
UDI/DI 00843576150522, REF 28-N4-44-114-44U, Lot Numbers: 2206140189, 2202220098;
UDI/DI 00843576101425, REF 28-N4-44-164-40S, Lot Numbers: B220324203;
UDI/DI 00843576101067, REF 28-N4-44-164-44S, Lot Numbers: B211011231, B211006018;
UDI/DI 00843576150652, REF 28-N4-44-164-44U, Lot Numbers: 2202030148, 2202040349, 2202040352, 2202040347, 2208190235;
UDI/DI 00843576101524, REF 28-N4-44-209-40S, Lot Numbers: B220824003;
UDI/DI 00843576151116, REF 28-N4-44-209-40U, Lot Numbers: 2202020151, 2206140102, 2208250013, 2202050009, 2202100078;
UDI/DI 00843576101197, REF 28-N4-44-209-44S, Lot Numbers: B220328360, B220614195, B220328357, B220328351;
UDI/DI 00843576150782, REF 28-N4-44-209-44U, Lot Numbers: 2203030286, 2107300026;
UDI/DI 00843576101432, REF 28-N4-46-164-42S, Lot Numbers: B220328378, B221021036, B220325147;
UDI/DI 00843576151024, REF 28-N4-46-164-42U, Lot Numbers: 2110050160, 2202040376;
UDI/DI 00843576101531, REF 28-N4-46-209-42S, Lot Numbers: B220329306, B221025297, B220326018;
UDI/DI 00843576151123, REF 28-N4-46-209-42U, Lot Numbers: 2110180197, 2202040375;
UDI/DI 00843576101203, REF 28-N4-46-209-46S, Lot Numbers: B220329254, B220322230;
UDI/DI 00843576150799, REF 28-N4-46-209-46U, Lot Numbers: 2110090005, 2202100283, 2202010117;
UDI/DI 00843576151222, REF 28-N4-46-259-42U, Lot Numbers: 2107200052;
|
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 |
640 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
|
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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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