Reported May 20, 2020 · Terminated

SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of…

C.R. Bard Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: C.R. Bard Inc · 8195 Industrial Blvd NE · Covington, GA · 30014-1497

Is this the product you have?

  • SureStep
  • Foley Tray System - Product UsageIntended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract
Lot codes and dates

7 of 7 products

Products covered by this recall
Model / numberBarcodesProduct as published
A304716A00801741104299UDI: 00801741104299 Lot Numbers: NGDX4745 (Exp. 03/20/2021)
NGDY0567 (Exp. 03/20/2021)
NGDW1548 (Exp. 11/30/2021)
NGDW0234 (Exp. 11/30/2021)
NGDX4088 (Exp. 11/30/2021)
NGDX4704 (Exp. 11/30/2021)
NGDY0568 (Exp. 11/30/2021)
Amount recalled
8392 units

Where it was sold

Why it was recalled

There is potential for a white paper-type residue attached to the catheter.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 20, 2021 · Data as of Sep 19, 5:29 PM UTC

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