Recall Z-0119-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0119-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-28

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-08-28. It names one FDA 510(k) clearance: K213481. Product: MEDLINE HEART CABG CDS, REF CDS983376R. Reason: Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-08-28
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 HEART CABG CDS, REF CDS983376R

Reason for recall

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.

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