Recalling Firm / Manufacturer

Smith & Nephew, Inc. Endoscopy Division

Product

DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for remote Control in a sterile field.

Code Information

Lot Numbers: 1548H, 1548J, 1718U, 1758F, 1848U, and 1928F.

Reason of Recall

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

Date Recall Initiated

August 07, 2008

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.

Contact

Al-Haya Medical Company
Riyadh
(01) 465 5075

Source of Information

U.S.FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.