Reported May 29, 2024 · Ongoing
Cascade IOMAX Cortical Module, REF: 190296-200
Cadwell Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cadwell Industries Inc · 909 N Kellogg St · Kennewick, WA · 99336-7669
Is this the product you have?
- Cascade IOMAX Cortical Module
- REF190296-200
- Lot codes and dates
- UDI-DI00840067100653/
- Serial numbers
19029603AA122300219029603AA122300319029603AA122300419029603AA122300519029603AA122300619029603AA122300719029603AA122301119029603AA122301219029603AA122301319029603AA122301419029603AA122301519029603AA122301619029603AA122301719029603AA122301819029603AA122301919029603AA122302019029603AA122302419029603AB122302119029603AB122302319029603AA122302519029603AA012400119029603AA012400219029603AA022400819029603AA012400719029603AA012401219029603AA012401719029603AA012400419029603AA012401019029603AA012401619029603AA022401019029603AA012401519029603AA122302619029603AA012400819029603AA012400919029603AA122302719029603AA122302819029603AA122302919029603AA012400319029603AA022400119029603AA122303019029603AA122300819029603AA122300919029603AA012401319029603AA122303119029603AA122300119029603AA022400219029603AA022400319029603AA022400419029603AA022400519029603AA022400619029603AA022400719029603AA012401419029603AA022400919029603AA0124011
- Amount recalled
- 54 units
Where it was sold
- Nationwide
- MD
Why it was recalled
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
This product could cause temporary or reversible health problems — stop using it.
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