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 / number Barcodes Product 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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