NAMIC recallZ-1806-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 12, 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
Products have a lack of sterility assurance.
FDA root cause category: Process control
What the company is doing
Medline issued a Medical Device Recall notice to its consignees on 03/12/2024 via email and US Mail. The notice explained the issue, potential risk, and requested destruction of the affected product. Those who further distributed the product were directed to notify those to whom they shipped the product.
Recall details
- Recall number
- Z-1806-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 12, 2024
- Posted by the FDA
- May 10, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 570 units
- Product code
- OEZ
- Distribution
- US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
Product description
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A
Code information (models, lots, serial numbers)
a) UDI/DI 10193489040456, Lot Numbers: 0000113192; b) UDI/DI 10193489044195, Lot Numbers: 0000113331; c) UDI/DI 10193489044386, Lot Numbers: 0000112999; d) UDI/DI 10193489044416, Lot Numbers: 0000113000; d) UDI/DI 10193489044935, Lot Numbers: 0000113187; e) UDI/DI f) UDI/DI g) UDI/DI h) UDI/DI i) UDI/DI j) UDI/DI k) UDI/DI l) UDI/DI m) UDI/DI n) UDI/DI o) UDI/DI p) UDI/DI q) UDI/DI
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- NAMIC 60011045Medline Industries, Inc. · Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60070582Medline Industries, Inc. · Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60071822Medline Industries, Inc. · Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60080085Medline Industries, Inc. · Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60100055Medline Industries, Inc. · Cardiovascular procedure kit1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94313).
- Z-1807-2024 · Open, ClassifiedNamic FLUID DELIVERY SET, REF 91300040
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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