Device recall

Z-2892-2011: Aquamantys 2.3 Bipolar Sealer Model #23-113-1. Product Usage: The Aquamantys…

FDA device recall · Class II · Salient Surgical Technologies, Inc

Key facts

Recall number (Z-number) Z-2892-2011
Recall event 59377
Product Aquamantys 2.3 Bipolar Sealer Model #23-113-1. Product Usage: The Aquamantys Bipolar Sealer is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue…
Recalling firm Salient Surgical Technologies, Inc
Recall class Class II
Status Terminated
Termination date Mar 9, 2012
510(k) numbers K052859

At a glance

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

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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