FDA recall Z-1049-2025

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-12-23

Report date

2025-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

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