FDA Device Recall Z-2721-2024

Fresenius Kabi USA, LLC · North Andover, MA

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.

Device

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

Lot / serial / GTIN: Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.

Quantity: 180 cases/4,500 pieces

Reason for recall

A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

Recall record

Recall number: Z-2721-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: US Distribution to states of: CO, ID, NJ, UT.
Recall initiated: 2024-08-01
Classified by FDA Center: 2024-09-04
FDA published: 2024-09-11
Recalling firm: Fresenius Kabi USA, LLC
Firm location: North Andover, MA

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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