Recall Z-2374-2015— Ethicon Endo-Surgery Inc

Class I FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2015-05-13, terminated 2016-05-02. FDA's recall record names no specific 510(k) clearance for this event. 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) 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.. Reason: 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..

Recalling firm

Ethicon Endo-Surgery Inc

Classification

Class I

Status

Terminated

Initiated

2015-05-13

Terminated

2016-05-02

Firm location

Blue Ash, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.