Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
Recall
- Recall Number
- Z-0210-2024
- Event Number
- 93297
- Firm
- Maquet Cardiovascular, LLC
- FEI Number
- 2242352
- Product Code
- GEI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 19, 2023
- Posted
- November 2, 2023
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
An Urgent Medical Device Removal notice was sent October 06, 2023 advising customers examine inventory, stop using, and remove any affected product from areas of use and return it to Getinge through Customer Service (888) 880-2874 between 6:00AM - 5:00PM PST. The notification should be forwarded to any system users and to any customers to which product was further distributed to. Complete and return the acknowledgement form to [email protected] or fax to (866) 326-9165.
US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.