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.
Enforcement
- Recall Number
- Z-2374-2015
- Event ID
- 71551
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ethicon Endo-Surgery Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 2, 2015
- Initiation Date
- May 13, 2015
- Classification Date
- August 26, 2015
- Termination Date
- May 2, 2016
- Address
- 4545 Creek Rd, N/A, Blue Ash, OH, 45242-2803, United States
Description
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.
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.
Model #SEDPRU01
Nationwide Distribution including OH, RI, TX & WA.
14 units