Class 2 Device Recall Interavascular SAS/Getinge

• Date Initiated by Firm: January 14, 2022
• Create Date: March 07, 2022
• Recall Status: Terminated on September 19, 2023
• Recall Number: Z-0729-2022
• Recall Event ID: 89573
• 510(K)Number: K954848
• Product Classification: Graft, vascular, synthetic/biologic composite - Product Code MAL
• Product: 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
• Code Information: Lot Number: 21B10 S/N: 1318567653 UDI: (01)00384401017608(11)210210(17)260131(21)1318567653GS(10)21B10
• Recalling Firm/ Manufacturer: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• Manufacturer 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
• FDA Determined Cause: Packaging process control
• Action: 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- Recall.us@getinge.com 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
• Quantity in Commerce: 1 unit
• Distribution: US Nationwide distribution in the state of MO.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MAL