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Recall Observatory FDA recall evidence

Device product

Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

Z-2551-2025

August 18, 2025

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 97466
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2551-2025

Official wording

Reason: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

Code information: Batch: 108159110

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.