Z-1807-2024Class II

Namic FLUID DELIVERY SET, REF 91300040

Name: Z-1807-2024 Namic FLUID DELIVERY SET, REF 91300040
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-03-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-03-12 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Namic FLUID DELIVERY SET, REF 91300040 on 2024-03-12. FDA classified it as Class II and gives the reason as "Products have a lack of sterility assurance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1807-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-12
Posted: 2024-05-10
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Namic FLUID DELIVERY SET, REF 91300040
Product code: FPA Set, Administration, Intravascular
Reason for recall: Products have a lack of sterility assurance.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 50 units
Distribution: US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
Product codes and lots: UDI/DI 20193489069096 (box), 10193489069099 (unit), Lot Numbers: 0000113381

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1807-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1806-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1807-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10

Product code FPA

K852140Class IINamic Contrast & Fluid Delivery Spikes(various)North American Instrument Corp. / cleared 1985-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)