Recalls / —

—#202670

Product

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

FDA product code

CAF — Nebulizer (Direct Patient Interface)

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K142153

Affected lot / code info

UDI/DI 140267047147818, Lot code 3B085

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

Medline issued a recall notice on 08/04/2023 to its consignees by mail and email. The notice explained the problem with the product, risk to use, and requested all affected product be destroyed. Distributors are directed to notify their customers and have the customers document and destroy any affected product. This should be included the customers quantities on the distributor response form.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2023-08-04

Posted by FDA

2023-09-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202670. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.