FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: 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.
- Recall number
- Z-2451-2008
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- 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.
- Status
- Terminated
- Initiated
- 2008-08-07
- Posted
- 2008-09-21
- Terminated
- 2012-05-08
- Reason
- Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
- 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
- 4,044 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.
- Lot, serial or model codes
- Lot Numbers:1458F, 1458J, and 1698J.
- 510(k) numbers
- ["K051326"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28