Ethicon Recalls SEDASYS Sedation Systems Due to Plastic Degradation
Ethicon is recalling 14 SEDASYS Computer-Assisted Personalized Sedation Systems because unspecified disinfecting methods caused the plastic material of the Control Unit to degrade.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 14 units of the SEDASYS Computer-Assisted Personalized Sedation System, model SEDPRU01. This integrated physiological monitoring and drug delivery system is intended to help physician-led teams administer 1% propofol injectable emulsion to sedate patients over 18 years old (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
The recall was initiated because Ethicon found that disinfecting methods not specified in the Instructions For Use (IFU) led to the degradation of the plastic material in the SEDASYS System Control Unit. The affected units were distributed nationwide, including in Ohio, Rhode Island, Texas, and Washington.
Healthcare facilities and users should stop using the affected SEDASYS systems and contact Ethicon Endo-Surgery Inc for instructions on how to return the devices or obtain a replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Ethicon Endo-Surgery Inc
- Category
- Medical Device — Sedation System
- Hazard
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model #SEDPRU01
Distribution
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