C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
C.R. Bard is recalling SureStep 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 involves a medical device with a reported contamination hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
C.R. Bard Inc. is recalling specific SureStep Foley Tray Systems and Intermittent Catheter Trays. The recall involves 33,850 units and kits distributed nationwide in the United States and in several international countries, including Canada, Mexico, and the United Arab Emirates.
The recall was initiated due to complaints indicating the presence of contamination on the surface of the Pericare wipes provided with these trays. The affected products are intended for urological use in the drainage, collection, or measurement of urine.
Consumers should stop using the affected products and contact C.R. Bard Inc. for instructions on how to return or dispose of them. The specific lot numbers and reference codes for the recalled items are listed in the official recall documentation.
The recalled product
- Product
- Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep"…
- Manufacturer
- C.R. Bard Inc
- Hazard
- Affected units
- 33,850
Distribution
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