Recall Z-1336-2023 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
| Date | Apr 4, 2023 (initiated Mar 6, 2023) |
| Status | Open, Classified |
| Reason | Some batches of product were not sterilized to their minimum sterilization specification. |
| Root cause | Process control |
| Action | An Urgent Medical Device Removal notification letter dated 3/3/23 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received the Hemopro lot(s) affected by this recall. Please, note that Distributed Affected Lot Number(s) appear on the device shelf boxes only. Please examine your inventory immediately to determine if you have any of the Hemopro with the product code/lot number(s) listed in this notice. " Should you have any affected product lot(s) as listed in this notification, please stop using and remove the complete device from areas of use. |
| Quantity | 2300 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Brazil, China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101274 | VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM Maquet Cardiovascular, LLC, Jun 11, 2010 |