C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
C.R. Bard Inc. is recalling specific Bardex and SureStep Foley catheter trays because complaints indicated surface contamination on 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text cites complaints of contamination but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
C.R. Bard Inc. is recalling specific Bardex I.C. Complete Care Foley Catheter Trays and SureStep Foley Tray Systems. The recall involves 212,580 units distributed worldwide, including the United States, Canada, and several other countries. The affected products contain Pericare wipes that were the subject of complaints.
The recall was initiated due to complaints received indicating the presence of contamination on the surface of the Pericare wipes provided with these catheter trays. The source text does not specify the type of contamination or report any illnesses or injuries associated with the use of these products.
Consumers who have these specific products should stop using them and contact C.R. Bard Inc. for further instructions. The affected products are identified by specific reference numbers and UDI codes listed in the official recall notice.
The recalled product
- Product
- Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741024341 *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252¿…
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 212,580
Distribution
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