TemporaryFDAOngoing
Can make you unwell for a while. Do not eat it.
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
Check your package for
UDI 00607567700406, Serial/Lot Number 3000547797
- Why
- Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
- Distributed
- US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Company
- Maquet Cardiovascular, LLC
- Announced
- Recall began