Preventive maintenance kit recalled over loosely tightened desiccant tube end caps
The Preventive Maintenance Kit ICEFX, batch 108159110, is recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. One unit is affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice describes an assembly issue in a maintenance kit without stating any patient consequence.
Plain-English summary
The Preventive Maintenance (PM) Kit ICEFX, material number SPRPM8000, is being recalled for batch 108159110. The recall covers 1 unit distributed in the United States and in Canada, France, Germany and Italy.
The recall was issued because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. The FDA classified the action as Class II. The notice does not describe a further consequence.
The holder of the affected kit should follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Maintenance Kit
- Affected units
- 1
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.
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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