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 / number Barcodes Product 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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