Recall Z-0991-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0991-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-31

Class I · Ongoing

Class I FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-12-31. It names one FDA 510(k) clearance: K213481. Product: Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6) ARTERIAL LINE INSERTION TRAY, Item Number ART475; 7) ARTERIAL LINE BUNDLE - OR, Item Number ART535A; 8) ARTERIAL LINE TRAY, Item Number ART545A; 9) ARTERIAL LINE INSERTION KIT, Item Number ART775C; 10) ARTERIAL LINE TRAY, Item Number ART840; 11) ARTERIAL LINE KIT, Item Number ART890B. Reason: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class I
Status: Ongoing
Initiated: 2024-12-31
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 General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6) ARTERIAL LINE INSERTION TRAY, Item Number ART475; 7) ARTERIAL LINE BUNDLE - OR, Item Number ART535A; 8) ARTERIAL LINE TRAY, Item Number ART545A; 9) ARTERIAL LINE INSERTION KIT, Item Number ART775C; 10) ARTERIAL LINE TRAY, Item Number ART840; 11) ARTERIAL LINE KIT, Item Number ART890B

Reason for recall

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

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