HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
Check against the official notice below — it lists the full affected range.
Maquet Cardiovascular, LLC is recalling one unit of HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft due to a labeling mismatch. The outer packaging is labeled as a bifurcated graft with dimensions of 16 x 8 mm and 40 cm length, while the inner sterile packaging is labeled as a straight graft with dimensions of 7 mm and 60 cm length. This mislabeling could result in implantation of an incorrect graft type.
If the wrong graft type were used during surgery, it could cause disruption of the vascular connection over time and lead to formation of a pseudo-aneurysm. The affected product has Lot Number 21B10, Serial Number 1318567653, and was distributed nationwide in Missouri. The recall source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: US Nationwide distribution in the state of MO. Quantity: 1 unit Lot/code info: Lot Number: 21B10 S/N: 1318567653 UDI: (01)00384401017608(11)210210(17)260131(21)1318567653GS(10)21B10
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.