FDA Device Recall Z-2514-2023

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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

Lot / serial / GTIN: UDI/DI 140267047147818, Lot code 3B085

Quantity: 18,000 units

Reason for recall

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

Recall record

Recall number: Z-2514-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: US Nationwide distribution.
Recall initiated: 2023-08-04
Classified by FDA Center: 2023-09-14
FDA published: 2023-09-20
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Firm location: Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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