—#72832

Product

DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Patient Tubeset. Catalog # 7211008. Bag is used for remote control in a sterile field.

FDA product code: HRX — Arthroscope
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051326
Affected lot / code info: Lot Numbers:1458F, 1458J, and 1698J.

Why it was recalled

Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.

Root cause (FDA determination)

Packaging process control

Action the firm took

Smith & Nephew Inc. Endoscopy Division contacted each affected user facility via confirmation letter and phone. An Urgent Product Correcetion Notification was sent on August 7, 2008. Users requested to discard the remote control bag form the kit and alternative suggestions provided. For further information please contact Paul Tiwari at 978-749-1397.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Worldwide Distribution including USA and countries of Canada, Chile, Colombia, Greece, France, Australia, Netherlands, South Africa, United Kingdom, Japan, Dubai, Germany, India, Malaysia, Switzerland, Belgium, Italy, and Puerto Rico.

Timeline

Recall initiated: 2008-08-07
Posted by FDA: 2008-09-21
Terminated: 2012-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72832. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.