Recall Z-1048-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1048-2025
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: K885179. Product: CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; 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

K885179 — INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELDBaxter Healthcare Corp·cleared 1989-08-09

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

CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; 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.