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).
- Company
- Maquet Cardiovascular, Llc
- Recall Initiated
- September 19, 2023
- Posted
- November 2, 2023
- Recall Number
- Z-0210-2024
- Firm Location
- Wayne, NJ
Reason for Recall
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Distribution
US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
Lot / Code Info
UDI-DI: 00607567700239, Lot: 3000313857.
Root Cause
Under Investigation by firm
Action Taken
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 VV6proPkg2023.act@getinge.com or fax to (866) 326-9165.