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U.S. Department of Health and Human Services

Class 1 Device Recall SEDASYS

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 Class 1 Device Recall SEDASYSsee related information
Date Initiated by FirmMay 13, 2015
Date PostedAugust 26, 2015
Recall Status1 Terminated 3 on May 02, 2016
Recall NumberZ-2374-2015
Recall Event ID 71551
PMA NumberP080009 
Product Classification Computer-assisted personalized sedation system - Product Code PDR
ProductSEDASYS 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.
Code Information Model #SEDPRU01
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information ContactMr. James Lucky
513-337-7439
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionSedasys, a Division of Ethicon Endo-Surgery, Inc. sent an Urgent Customer Notification letter dated May 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Please distribute this information to all staff within your facility who use the SEDASYS System 2. Complete the Business Reply Form (BRF) (Attachment A) confirming receipt of this notice within three (3) business days. The BRF may be given to your sales or service representative or sent to Sedasys by email at SedasysTechSupport@its.jnj.com. 3. Keep this notice visibly posted in your facility for awareness. 4. If you have any questions or concerns regarding the condition of your SEDASYS System including the Control Units, please contact your Sales or Service Representative. If you need clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-800-SEDASYS (1-800-733-2797). If you need additional communications packages, contact 1-800-SEDASYS and reference Event 052715SED01. For questions regarding this recall call 513-337-7439.
Quantity in Commerce14 units
DistributionNationwide Distribution including OH, RI, TX & WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = PDR
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