MEDLINE ARTERIAL LINE PACK recalled over labeling errors

Recall date

December 23, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Hep…

Recall number

Z-1049-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

US: FL, KS, ND, PA, WA, WV, IL, WA

Why it was recalled

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.