FDA-Device2025-02-05Class II

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

MEDLINE INDUSTRIES, LP - Northfield
Hazard

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

Sold states
US: FL, KS, ND, PA, WA, WV, IL, WA
Affected count
50 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1049-2025

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