Recalls / —

—#206940

Product

Namic FLUID DELIVERY SET, REF 91300040

FDA product code

FPA — Set, Administration, Intravascular

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K852140

Affected lot / code info

UDI/DI 20193489069096 (box), 10193489069099 (unit), Lot Numbers: 0000113381

Why it was recalled

Products have a lack of sterility assurance.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.

Timeline

Recall initiated

2024-03-12

Posted by FDA

2024-05-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #206940. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.