Recall Z-1049-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1049-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-23

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-12-23. It names one FDA 510(k) clearance: K213481. 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..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-12-23
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K213481 — Medline General Surgery TrayMedline Industries, Inc.·cleared 2022-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.