FDA recall Z-0003-2022

Product

Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

Reason for recall

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

Distribution

Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.

Key facts

Status

Ongoing

Initiation date

2021-09-13

Report date

2021-10-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0003-2022