[pending] Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.3
Pending LLM rewrite. Source: FDA_DEVICE Z-2402-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Reusable electrodes may not meet expected performance levels.
The recalled product
- Product
- Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Devices
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 (6)
- All Lots: / UDI: CSK-TC10:00813250010107
- CSK-TC10-3M: 00813250011524
- CSK-TC15 00813250010114
- CSK-TC15-3M: 00813250011548 CSK-TC20: 0081325001140
- CSK-TC5: 00813250010091
- CSK-TC5-3M: 00813250011531
Distribution
Distributed nationwide across the United States.
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