Recall Z-2514-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-2514-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-04

Class I · Ongoing

Class I FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-08-04. It names one FDA 510(k) clearance: K142153. Product: HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U. Reason: Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class I
Status: Ongoing
Initiated: 2023-08-04
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K142153 — HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML; 5ML; 15MLTeleflexmedical, Inc.·cleared 2015-04-29

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

HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U

Reason for recall

Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.

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