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

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

Getinge issued Urgent Medical Device Letter onJanuary 14, 2022, (via FedEx overnight) with adult signature required. Letter states reason for recall, health risk and action to take: Actions to be taken: " If you have already implanted the above-mentioned device, kindly notify us as soon as possible by contacting your Getinge representative or Customer Service (at 1-888-943-8872, options 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. You will be contacted shortly by our Medical Affairs Officer in order to discuss the appropriate follow up. " Please examine your inventory immediately to determine if you have the HEMASHIELD GOLD Product Knitted Microvel Double Velour Straight Vascular Graft (D: 7 mm; L: 60 cm) SN 1318567653, Ref Number M002020952070. " Should you have the un-used affected product, you are eligible for credit upon receipt of Response Form (see page 4). " Please contact Getinge Customer Service at 1-888-943-8872, (press option 2) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request shipping instructions to return any affected product. " Pack the product to be returned with the appropriate return documents. " Whether you have affected product or not, please complete and sign the attached URGENT MEDICAL DEVICE REMOVAL RESPONSE FORM (page 4) to acknowledge this recall and return the completed form to Getinge by e-mailing a scanned copy to Hemashieldgold- [email protected] or by FAX to 8772811346. " Please forward this information to all current and potential Hemashield Gold Knitted Microvel Double Velour Vascular Graft users within your hospital / facility. " If you are a distributor who has shipped any affected product to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or, for technical questions, please contact Customer Service (at 1-888-943-8872, options 2), Monday th