Reported Jan 25, 2023 · Ongoing
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
Bolton Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bolton Medical Inc. · 799 International Pkwy · Sunrise, FL · 33325-6220
Is this the product you have?
- RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
- Lot codes and dates
113 of 113 products
Products covered by this recall Model / number Barcodes Product as published 28-N4-22-159-22S00843576100954UDIUDI/DI 00843576100954, , Lot Numbers: B210719245, B210619174 28-N4-24-099-24S00843576100831UDI/DI 00843576100831, , Lot Numbers: B220323028, B211222140 28-N4-24-099-24U00843576150423UDI/DI 00843576150423, , Lot Numbers: 2204210157, 2204210158, 2208230256, 2208250035 28-N4-24-159-24S00843576100961UDI/DI 00843576100961, , Lot Numbers: B220104035, B220824113, B210612293, B220201173 28-N4-24-159-24U00843576150553UDI/DI 00843576150553, , Lot Numbers: 2202090215, 2202090293 28-N4-24-259-24S00843576101227UDI/DI 00843576101227, , Lot Numbers: B220210257, B220210257 28-N4-24-259-24U00843576150812UDI/DI 00843576150812, , Lot Numbers: 2210110048, 2210110049, 2210100193 28-N4-26-104-26S00843576100848UDI/DI 00843576100848, , Lot Numbers: B220226088, B220414055 28-N4-26-104-26U00843576150430UDI/DI 00843576150430, , Lot Numbers: 2110070047, 2202020135, 2202010164, 2112210201, 2202120154, 2202260085, 2204140202 28-N4-26-164-26S00843576100978UDI/DI 00843576100978, , Lot Numbers: B220316171, B210927313, B210602367, B220303176, B220316275, B220204220, B220210181, B220210141, B211215127, B220203121 28-N4-26-164-26U00843576150560UDI/DI 00843576150560, , Lot Numbers: 2110130276, 2203030136, 2203040029, 2206140190, 2202280430, 2203030197, 2202020185, 2202090218, 2202100235 28-N4-26-204-26U00843576150690UDI/DI 00843576150690, , Lot Numbers: 2201150114, 2204150063, 2206130239 28-N4-28-104-28S00843576100855UDI/DI 00843576100855, , Lot Numbers: B220323030, B220323295, B221024139, B221026118, B221024275 28-N4-28-104-28U00843576150447UDI/DI 00843576150447, , Lot Numbers: 2108090034, 2206140194, 2112170035, 2202100079, 2202110166, 2202160141 28-N4-28-164-24U00843576150935UDI/DI 00843576150935, , Lot Numbers: 2202160143, 2202160143, 220614019 28-N4-28-164-28S00843576100985UDI/DI 00843576100985, , Lot Numbers: 2202150157, B210713325, B211019291, B211218042, B211217126, B211228051, B211228183, B211019294, B220302187, B220308234, B220308196, B220315291, B220315290, B220316085, B220224046, B211215130, B220211180, B220215104, B220215116, B211218039, B220215116 28-N4-28-164-28U00843576150577UDI/DI 00843576150577, , Lot Numbers: 2202140139, 2203160088, 2203110300, 2208190099, 2203110300, 2208230038 28-N4-28-204-24S00843576101449UDI/DI 00843576101449, , Lot Numbers: B220216144 28-N4-28-204-24U00843576151031UDI/DI 00843576151031, , Lot Numbers: 2203040078, 2203040076 28-N4-28-204-28S00843576101111UDI/DI 00843576101111, , Lot Numbers: B220222108, B220222103, B220222101, B220216186, B220315302 - Amount recalled
- 640 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The product may be shorter than packaging indicates
This product could cause temporary or reversible health problems — stop using it.
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