Device recall

Z-2078-2009: DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked…

FDA device recall · Class II · Smith & Nephew, Inc. Endoscopy Division

Key facts

Recall number (Z-number) Z-2078-2009
Recall event 52211
Product DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction Catalog Number: 7211006
Product code HRX
Recalling firm Smith & Nephew, Inc. Endoscopy Division
Recall class Class II
Status Terminated
Termination date May 8, 2012
510(k) numbers K051326
FEI number 3003604053

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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