Reported Mar 16, 2022 · Terminated
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement…
Maquet Cardiovascular, LLC
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: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- HEMASHIELD GOLD KNITTED MICROVEL
- DOUBLE VELOUR VASCULAR GRAFT- D7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
- Product Code/REF NumberM002020952070
- Lot codes and dates
- Lot Number21B10
- S/N1318567653
- UDI(01)00384401017608(11)210210(17)260131(21)1318567653GS(10)21B10
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- MO
Why it was recalled
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
This product could cause temporary or reversible health problems — stop using it.
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