Device recall

Z-1785-2014: Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product…

FDA device recall · Class I · Convatec Inc.

Key facts

Recall number (Z-number) Z-1785-2014
Recall event 68292
Product Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
Product code KNT
Recalling firm Convatec Inc.
Recall class Class I
Status Terminated
Termination date Aug 28, 2015
FEI number 3011987967

At a glance

  • None 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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