Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
FDA Recall #Z-2551-2025 — Class II — August 18, 2025
Product Description
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Reason for Recall
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Recalling Firm
Boston Scientific Corporation — Maple Grove, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 unit
Distribution
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
Code Information
Batch: 108159110
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated