C.R. Bard SureStep Foley Catheter Tray Recalled for Sterile Barrier Defect
C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The recall affects 33,380 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where potential sterile barrier compromise could lead to serious infection, but no illnesses or injuries have been reported. The FDA classified this as Class II.
Plain-English summary
C.R. Bard Inc is recalling SureStep Foley Catheter Trays (Catalog A800361) due to potential packaging defects that may compromise the sterile barrier. The product is a Foley catheter tray with pre-assembled lubricant, used in urinary catheterization procedures.
The recall involves 33,380 units distributed nationwide. Affected lot numbers are: NGFR0310, NGFR0311, GFR2807, NGFR2829, NGFR3571, NGFR5475, and NGFR5481. Packaging defects could compromise the sterile barrier, which is essential for preventing contamination during use.
Consumers and healthcare providers in possession of affected lot numbers should contact C.R. Bard Inc for further instructions.
The recalled product
- Product
- Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
- Manufacturer
- C.R. Bard Inc
- Hazard
- packaging-defect
- sterile-barrier-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Catalog A800361
- Lots: NGFR0310
- UDI (01)00801741073939(17)201220(10)
- NGFR0311
- UDI N(01)00801741073939(17)201220(10)
- GFR2807
- NGFR2829
- NGFR3571
- NGFR5475
- nd NGFR5481 UDI (01)00801741073939(17)201220(10)
Distribution
Distributed nationwide across the United States.
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