NAMIC recallZ-1807-2024 · 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-1807-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 12, 2024
- Posted by the FDA
- May 10, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 50 units
- Product code
- FPA
- FDA submissions
- K852140
- 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 FLUID DELIVERY SET, REF 91300040
Code information (models, lots, serial numbers)
UDI/DI 20193489069096 (box), 10193489069099 (unit), Lot Numbers: 0000113381
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NAMIC 91300040Medline Industries, Inc. · Set, administration, intravascular1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K852140 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NAMIC 64000935Navilyst Medical, Inc. · Set, administration, intravascular1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 94313).
- Z-1806-2024 · Open, Classifiednamic 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 HEA…
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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