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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences. The hazard involves material degradation due to improper use of disinfectants, with no reported injuries or illnesses in the source text.
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 I-II
- 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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