Z-2551-2025 Class II Ongoing

Recalled by Boston Scientific Corporation — Maple Grove, MN

Recall Details

Product Type
Devices
Report Date
September 17, 2025
Initiation Date
August 18, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

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.

Distribution Pattern

Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)

Code Information

Batch: 108159110