SEDASYS Computer-Assisted Personalized Sedation System recall: Impurity Out of Spec
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide…
Why was SEDASYS Computer-Assisted Personalized Sedation System recalled?
Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.
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?
Model #SEDPRU01
- Product
- SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide…
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 14 units
- Distribution
- Nationwide Distribution including OH, RI, TX & WA.
- Recall date
- September 2, 2015
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)