Z-0121-2025 Class II Ongoing
FDA device recall Z-0121-2025 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: 123 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 23, 2024
- Initiation Date
- Aug 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 kits
Product Description
MEDLINE OPEN HEART PACK, REF DYNJ66216C
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 40193489853361 (case), 10193489853360 (each), Lot Numbers: 23LBM368, 23LBH354
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0121-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026