Device recall

Z-2391-2011: Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove…

FDA device recall · Class I · Vygon Corporation

Key facts

Recall number (Z-number) Z-2391-2011
Recall event 58794
Product Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill Medical Systems AMS-9189CP (Dressing Change Kit)-Large Glove. The devices intended use is a Dressing Change Kit.
Product code LKB
Recalling firm Vygon Corporation
Recall class Class I
Status Terminated
Termination date Jun 18, 2012
FEI number 2245270

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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