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Terminated

DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction Catalog Number: 7211006

FDA Recall Z-2078-2009 · Posted 2009-09-21

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeHRX
Date Initiated2009-05-27
Date Terminated2012-05-08
Product Quantity67,697 units

Reason for Recall

The sterility of the device cannot be assured

Firm Action

Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.

Root Cause

Package design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051326SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEMSmith & Nephew, Inc. · 2005-06-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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