Z-0124-2025 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

FDA device recall Z-0124-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Aug 28, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 22 kits.

Recall Details

Product Type
Devices
Report Date
Oct 23, 2024
Initiation Date
Aug 28, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22 kits

Product Description

MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840

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.

Distribution Pattern

US Nationwide distribution.

Code Information

UDI/DI 40195327185078 (case), 10195327185077 (each), Lot Numbers: 24BMF235

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0124-2025
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.