Recall Z-0403-2022 ยท MAL Graft, Vascular, Synthetic/Biologic Composite
Maquet Cardiovascular, LLC
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
| Date | Dec 1, 2021 |
| Status | Terminated |
| Reason | There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890. |
| Root cause | Labeling Change Control |
| Action | And URGENT MEDICAL DEVICE REMOVAL notification letter dated 12/1/21 was sent to customers. Actions to be taken: " If you have already implanted one of the above-mentioned devices, 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 one of the Hemashield Gold Knitted Bifurcat |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of IL and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp., Feb 1, 1996 |