Recall Z-1807-2024— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1807-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-12

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-03-12. It names one FDA 510(k) clearance: K852140. Product: Namic FLUID DELIVERY SET, REF 91300040. Reason: Products have a lack of sterility assurance..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-03-12
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K852140 — NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)North American Instrument Corp.·cleared 1985-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Namic FLUID DELIVERY SET, REF 91300040

Reason for recall

Products have a lack of sterility assurance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.