Z-2514-2023Class I

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

Name: Z-2514-2023 HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-08-04
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-08-04 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U on 2023-08-04. FDA classified it as Class I and gives the reason as "Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2514-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-08-04
Posted: 2023-09-14
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 18,000 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 140267047147818, Lot code 3B085

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2514-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2514-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-14

Product code CAF

K142153Class IIHudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3Ml;5ml;15mlTeleflexmedical, Inc. / cleared 2015-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)