Recall Z-3061-2024— MEDLINE INDUSTRIES, LP - Northfield

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-04-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Number DYNJ54386C ; 5) LARGE BURN PACK , Pack Number DYNJ69770; 6) LARGE BURN PACK , Pack Number DYNJ69770A ; 7) SMALL BURN PACK , Pack Number DYNJ69797; 8) SMALL BURN PACK , Pack Number DYNJ69797A ; 9) BURN PACK-LF, Pack Number DYNJ82534; 10) BURN PACK-LF, Pack Number DYNJ82534H ; 11) BASIC BURN PACK , Pack Number DYNJ82729; 12) BURN PACK , Pack Number DYNJ83254; 13) BURN PACK , Pack Number DYNJ84744. Reason: 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..

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Classification

Class II

Status

Ongoing

Initiated

2024-04-08

Firm location

Northfield, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.