FDA recall Z-3128-2024

Medtronic Perfusion Systems · Class II · device

Product

Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

Reason for recall

During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).

Distribution

Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.

Key facts

Status
Ongoing
Initiation date
2024-07-09
Report date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3128-2024