Z-2551-2025 Class II Ongoing
FDA device recall Z-2551-2025 was initiated by Boston Scientific Corporation on August 18, 2025 and is designated Class II. Reason for recall: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. The recall status is ongoing. Affected quantity: 1 unit.
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