FDA recall Z-3072-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A

Reason for recall

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.

Distribution

US: TX, IL, CA

Key facts

Status
Ongoing
Initiation date
2024-06-18
Report date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3072-2024