FDA recall Z-2985-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-04-08
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-2985-2024