Boston Scientific Preventive Maintenance Kit ICEFX Recalled for Loose End Caps
Boston Scientific is recalling the Preventive Maintenance Kit ICEFX because certain desiccant tube subassemblies have end caps that were not correctly tightened during manufacturing. The affected batch was distributed in Canada, France, Germany, Italy, and the United States.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a manufacturing defect that directly affects product function. No illnesses or injuries have been reported, placing this in the 'risk-of-harm' category where injury has not yet occurred.
Plain-English summary
Boston Scientific Corporation is recalling the Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000.
Certain desiccant tube subassemblies in this kit were manufactured with end caps that were not correctly tightened. The affected batch number is 108159110. The kit was distributed in Canada, France, Germany, Italy, and the United States.
Customers who have received kits from this batch should contact Boston Scientific Corporation for instructions regarding their units.
The recalled product
- Product
- Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
- Manufacturer
- Boston Scientific Corporation
- Hazard
- manufacturing-defect
- loose-seal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch: 108159110
Distribution
Distributed nationwide across the United States.
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