FDA recall Z-1316-2024

Medtronic Perfusion Systems · Class II · device

Product

Medtronic DLP Vessel Cannula, Model Number REF 30000

Reason for recall

Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.

Distribution

US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK

Key facts

Status
Ongoing
Initiation date
2024-02-07
Report date
2024-03-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2024