Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, o
FDA device recall Z-0210-2024 · posted 2023-11-02 · Open, Classified
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GEI
- Distribution
- US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
- Date initiated
- 2023-09-19
- Date posted
- 2023-11-02
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 (K091733) | Maquet Cardiovascular, LLC | 2009-08-28 |