Recall Z-2444-2024— MEDLINE INDUSTRIES, LP - Northfield

Class I 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 procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ; 5) ARTERIOGRAM PACK, Pack Number DYNJ53018; 6) CATH PACK , Pack Number DYNJ57729C ; 7) PEDS CATH PACK, Pack Number DYNJ66856; 8) PEDS CATH PACK, Pack Number DYNJ66856A ; 9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ; 10) CATH LAB PACK , Pack Number DYNJ84617; 11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A. 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 I

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.