RecallRadar

FDA Device recall Z-1049-2025

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

On 2025-02-05 the FDA classified a Class II recall of MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating by Medline Industries Northfield, citing certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1049-2025
ClassificationClass II
Statusongoing
Initiated2024-12-23
Published2025-02-05
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
DistributionFL, IL, KS, ND, PA, WA, WV

Product

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

Reason

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

Identifiers

code_infoUDI/DI 10195327561543 (ea) 40195327561544 (cs), Lot Numbers: 24IMA276, 24JMI065, 24FMF777, 24GMG420

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1049-2025%22

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