Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
FDA Recall #Z-1002-2026 — Class I — November 11, 2025
Product Description
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Reason for Recall
Devices are not suitable for organ transplant.
Recalling Firm
AVID Medical, Inc. — Toano, VA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
380 units
Distribution
US Nationwide distribution in the states of FL, GA and Puerto Rico.
Code Information
Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated