Reported Sep 29, 2021 · Ongoing

Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock"…

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 A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberBarcodesProduct as published
A319516AM00801741073892Lot NGFS1691, UDI (01)00801741073892(17)201228(10)
00801741073892NGFR3282, UDI (01)00801741073892(17)201228(10)
0080174107389200801741073892and NGFR4423, UDI (01)00801741073892(17)201228(10) Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(17)201228(10)
Amount recalled
8170 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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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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.