Device recall

Z-2333-2016: SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK…

FDA device recall · Class III · C.R. Bard, Inc.

Key facts

Recall number (Z-number) Z-2333-2016
Recall event 74610
Product SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Product code KNX
Recalling firm C.R. Bard, Inc.
Recall class Class III
Status Terminated
Termination date Dec 5, 2017
FEI number 1018233

At a glance

  • None 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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