FDAFDA · Food and drugs·Recall number Z-2374-2015
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
Published September 2, 2015 · Recall initiated: May 13, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon Endo-Surgery Inc
- Distributor
- Nationwide Distribution including OH, RI, TX & WA.
- Lot
- Model #SEDPRU01
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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