C.R. Bard Foley Catheter Tray recalled for potential packaging defects
C.R. Bard Inc is recalling approximately 29,890 units of Foley catheter trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.
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: FDA Class II recall with no reported illnesses or injuries. The hazard—potential packaging defects affecting the sterile barrier on an invasive medical device—represents a risk-of-harm product, meeting the rubric criterion for High severity.
Plain-English summary
C.R. Bard Inc is recalling Catalog A902916, a Foley catheter tray that includes SureStep Foley Tray, Lubricath, Urine Meter, and StatLock Stabilization Device. Approximately 29,890 units were distributed nationwide.
The FDA identified potential packaging defects that may impact the sterile barrier. No illnesses or injuries have been reported.
The affected product is used in healthcare settings. Individuals who have received these products should identify whether they have affected units by checking the lot numbers listed in the recall notice.
Consumers and healthcare providers with affected units should contact C.R. Bard Inc for information about replacement or next steps.
The recalled product
- Product
- Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Hazard
- packaging-defect
- sterility-risk
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 (8)
- Catalog A902916
- Lots: NGFR3115
- UDI (01)00801741074073(17)251228(10)
- NGFR3278
- NGFR3279
- NGFS1308
- NGFS1309
- and NGFS1366
Distribution
Distributed nationwide across the United States.
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