C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
C.R. Bard is recalling 12,463 Foley and intermittent catheter trays because complaints indicated contamination on the surface of the included Pericare wipes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves contamination on a medical device without reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
C.R. Bard Inc is recalling 12,463 trays and kits of various Foley and intermittent catheter systems. The affected products include Bardex Lubricath Foley Catheter Trays, SureStep Foley Tray Systems, and Bard Urine Meter Foley Catheter Trays. These products are intended for urological use in the drainage, collection, or measurement of urine.
The recall was initiated due to complaints indicating the presence of contamination on the surface of the Pericare wipes provided with these trays. The source text does not specify the nature of the contamination or report any illnesses or injuries.
The affected products were distributed nationwide in the United States and in Bahrain, Canada, Costa Rica, Guatemala, Mexico, Saudi Arabia, and the United Arab Emirates. Consumers and healthcare facilities should stop using the affected products and contact C.R. Bard Inc for further instructions.
The recalled product
- Product
- Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822 SureStep" Foley Tray System with Bardex¿ Lubricath Temp…
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 12,463
Distribution
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