Safety Alert: Class II: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
healthClass IIRecalled on Sep 17, 2025
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
🔢 1 unit
Sold At: Boston Scientific Corporation(Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy.)
Recall #: FDA-DEVICE-Z-2551-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Batch: 108159110
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Summary
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Boston Scientific Corporation for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.