—#203857

Product

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).

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K091733
Affected lot / code info: UDI-DI: 00607567700239, Lot: 3000313857.

Why it was recalled

Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.

Timeline

Recall initiated: 2023-09-19
Posted by FDA: 2023-11-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203857. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.