Reported Mar 3, 2021 · Terminated
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid…
Natus Manufacturing Limited
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: Natus Manufacturing Limited · Ida Business Park · Galway, N/A · N/A
Is this the product you have?
- Ref
NT821731CNatus EDS 3 CSF External
- Drainage System - Product Usageindicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
- Lot codes and dates
- Lot # 118000422298
- Amount recalled
- 7 units
Where it was sold
- Nationwide
- NY
Why it was recalled
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
This product could cause temporary or reversible health problems — stop using it.
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