Device recall

Z-2447-2012: Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description…

FDA device recall · Class II · Applied Medical Resources Corp

Key facts

Recall number (Z-number) Z-2447-2012
Recall event 63100
Product Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY…
Product code FGE
Recalling firm Applied Medical Resources Corp
Recall class Class II
Status Terminated
Termination date Mar 22, 2013
510(k) numbers K910006
FEI number 2027111

At a glance

  • 1–9 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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