Device recall

Z-0377-2007: Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF…

FDA device recall · Class II · Cook Urological, Inc.

Key facts

Recall number (Z-number) Z-0377-2007
Recall event 37115
Product Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
Product code FED
Recalling firm Cook Urological, Inc.
Recall class Class II
Status Terminated
Termination date May 1, 2008
510(k) numbers K043418
FEI number 1825146

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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