Devices

Device Recall DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction

Model / Serial
Lot Numbers: 0149J, 0149H, 0149K, 0769P, 0799N, 0899K, 0919K, 09609W, 1688L, 1788H, 1798F, 1918F, 1928H, 1928HR, 1998X, 2218H, 2258F, 2278F, 2328H, 2388J, 2398F, 2418T, 2478K, 2758U, 2758Y, 2758Y, 2778F, 2778FR, 2898F, 2908X, 2908Y, 3048N, 3098F, 3258U, 3258V, 3468U, and 3468V.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, Puerto Rico, France, Asia Pacific, Belgium, Canada, Norway, Thailand, The Netherlands, Malaysia, Brazil, Argentina, Chile, Colombia, Costa Rica, Venezuela, Turkey, Israel, Germany, UAE, Greece, and South Africa.
Product Description
DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction || Catalog Number: 7211005
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
1 Event
- Recall of Device Recall DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction

Manufacturer

Smith & Nephew, Inc. Endoscopy Division

Manufacturer Address
Smith & Nephew, Inc. Endoscopy Division, 150 Minuteman Drive, Andover MA 01810-1031
Source
USFDA

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