Z-2448-2008

DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable...

Name: Z-2448-2008 DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2008-08-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2008-08-07 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for... on 2008-08-07. The reason FDA records is "Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2448-2008
Status: Terminated
Initiated: 2008-08-07
Posted: 2008-09-21
Terminated: 2012-05-08
Recalling firm: Smith & Nephew, Inc.
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.
Product code: HRX Arthroscope
Reason for recall: Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 11,469 units
Distribution: 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.
Product codes and lots: Lot Numbers: 1548H, 1548J, 1718U, 1758F, 1848U, and 1928F.

Product code HRX

K051326Class IISmith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. / cleared 2005-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)