Medline Open Heart Nimc Kit, Ref Dynj908840 recallZ-0124-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Aug 28, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline issued an UREGENT MEDICAL DEVICE NOTIFICATION to its consignees on 08/28/2024 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee quarantine the product and response to obtain labeling to be placed on the affected inventory. Distributors are directed to notify those to whom they shipped the affected product.
Recall details
- Recall number
- Z-0124-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 28, 2024
- Posted by the FDA
- Oct 17, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 22 kits
- Product code
- OEZ
- Distribution
- US Nationwide distribution.
Product description
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
Code information (models, lots, serial numbers)
UDI/DI 40195327185078 (case), 10195327185077 (each), Lot Numbers: 24BMF235
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ908840Medline Industries, Inc. · Cardiovascular procedure kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95393).
- Z-0119-2025 · Open, ClassifiedMEDLINE HEART CABG CDS, REF CDS983376R
- Z-0120-2025 · Open, ClassifiedMEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
- Z-0121-2025 · Open, ClassifiedMEDLINE OPEN HEART PACK, REF DYNJ66216C
- Z-0122-2025 · Open, ClassifiedMEDLINE OPEN HEART, REF DYNJ904261B
- Z-0123-2025 · Open, ClassifiedMEDLINE KIT CV I II, REF DYNJ906071B
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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