Ref: NT821731C recall: Endotoxin
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral…
Why was Ref: NT821731C recalled?
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 118000422298
- Product
- Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral…
- Recalling firm
- Natus Manufacturing Limited
- Quantity
- 7 units
- Distribution
- US Nationwide distribution in the state of NY.
- Recall date
- March 3, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)