Reported Sep 29, 2021 · Ongoing

Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

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?

  • Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberBarcodesProduct as published
A303316A00801741073793Lots: NGEVX103 (exp. 08/31/2022), UDI (01)00801741073793(17)201220(10)
00801741073793NGFR3290 (02/28/2023), UDI (01)00801741073793(17)201220(10)
00801741073793NGFR3291 (exp. 02/28/2023), UDI (01)00801741073793(17)201220(10)
00801741073793and NGFR4542 (exp. 02/28/2023) UDI (01)00801741073793(17)201220(10)
Amount recalled
11,600 units

This recall covers 21 products

The agency filed one notice per product. You are reading one of them; the other 20 are below.

8 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

There is potential for packaging defects that may impact the sterile barrier.

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

Data as of Sep 19, 7:32 PM UTC

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