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 Recall Z-2451-2008 · Posted 2008-09-21
Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeHRX
Date Initiated2008-08-07
Date Terminated2012-05-08
Product Quantity4,044 units
Reason for Recall
Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
Firm Action
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.
Root Cause
Packaging process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.