HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl… recallZ-2514-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Aug 4, 2023

Class I Open, Classified All recalls posted in September 2023

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number: Z-2514-2023
Recall class: Class I (most serious)
Status: Open, Classified
Initiated by the company: Aug 4, 2023
Posted by the FDA: Sep 14, 2023
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 18,000 units
Product code: CAF
FDA submissions: K142153
Distribution: US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 140267047147818, Lot code 3B085

Other devices under the same FDA submission

1 device cleared under K142153 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

HUDSON RCI IPN049200
Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)
2 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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