Reported Jan 25, 2023 · Ongoing
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-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-M4-XX-XXX-XXX
- Lot codes and dates
71 of 71 products
Products covered by this recall Model / number Barcodes Product as published 28-M4-24-150-24U0084357610026800843576149731UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, , Lot Numbers: 2204210015, 2208250004, 2208250003 28-M4-26-095-26U00843576149618UDI/DI 00843576149618, , Lot Numbers: 2112210189 28-M4-26-155-26U00843576149748UDI/DI 00843576149748, , Lot Numbers: 2208240053, 2208250164, 2208220204 28-M4-28-095-28S00843576100039UDI/DI 00843576100039, , Lot Numbers: B220211367, B220129307, B220211163 28-M4-28-095-28U00843576149625UDI/DI 00843576149625, , Lot Numbers: 2208220081 28-M4-28-155-24U00843576150119UDI/DI 00843576150119, , Lot Numbers: 2210110060, 2202150279, 2202150279 28-M4-28-155-28S00843576100169UDI/DI 00843576100169, , Lot Numbers: B220209262 28-M4-28-155-28U00843576149755UDI/DI 00843576149755, , Lot Numbers: 2208240183 28-M4-28-195-24U00843576150218UDI/DI 00843576150218, , Lot Numbers: 2202030119 28-M4-28-195-28U00843576149885UDI/DI 00843576149885, , Lot Numbers: 2109150299 28-M4-28-250-24U00843576150317UDI/DI 00843576150317, , Lot Numbers: 2202100029 28-M4-28-250-28U00843576150010UDI/DI 00843576150010, , Lot Numbers: 2202010127 28-M4-30-095-30S00843576100046UDI/DI 00843576100046, , Lot Numbers: B220228338 28-M4-30-095-30U00843576149632UDI/DI 00843576149632, , Lot Numbers: 2208240127, 2112140029, 2202070140 28-M4-30-155-26U00843576150126UDI/DI 00843576150126, , Lot Numbers: 2203080218 28-M4-30-155-30S00843576100176UDI/DI 00843576100176, , Lot Numbers: B220825157, B211229047, B220211164, B211228037 28-M4-30-155-30U00843576149762UDI/DI 00843576149762, , Lot Numbers: 2202100215, 2208240129 28-M4-30-200-26S00843576100633UDI/DI 00843576100633, , Lot Numbers: B220207438 28-M4-30-200-30S00843576100305UDI/DI 00843576100305, , Lot Numbers: B220118082 28-M4-30-250-26S00843576100732UDI/DI 00843576100732, , Lot Numbers: B220202152 - Amount recalled
- 129 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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