Device recall

Z-2213-2010: DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video…

FDA device recall · Class II · Minntech Corp

Key facts

Recall number (Z-number) Z-2213-2010
Recall event 56189
Product DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.
Product code FEB
Recalling firm Minntech Corp
Recall class Class II
Status Terminated
Termination date Dec 17, 2011
510(k) numbers K914145
FEI number 2150060

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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