FDA Device Recall Z-0006-2024

Fresenius Medical Care Holdings, Inc. · Waltham, 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. Distribution is nationwide and the recall remains in progress.

Device

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Lot / serial / GTIN: UDI-DI: 16945060500125; All Lots

Quantity: 124,773 boxes total

Reason for recall

There is a potential for blood backfill leakage and foreign material.

Recall record

Recall number: Z-0006-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2023-08-08
Classified by FDA Center: 2023-10-06
FDA published: 2023-10-18
Recalling firm: Fresenius Medical Care Holdings, Inc.
Firm location: Waltham, 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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