SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delive

FDA device recall Z-2374-2015 · posted 2015-08-26 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

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.

Action taken

Sedasys, 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.

Root cause

Device Design

Status

Terminated

Product code

PDR

Quantity affected

14 units

Distribution

Nationwide Distribution including OH, RI, TX & WA.

Date initiated

2015-05-13

Date posted

2015-08-26

Date terminated

2016-05-02

Location

Blue Ash, OH