C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
C.R. Bard Inc. is recalling SureStep Foley and Intermittent Catheter Trays because complaints indicated contamination on the surface of the included Pericare wipes.
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: The recall is classified as FDA Class II. Per the rubric, Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
C.R. Bard Inc. is recalling specific SureStep Foley Tray Systems and Intermittent Catheter Trays that contain Pericare wipes. The recall was initiated due to complaints received indicating the presence of contamination on the surface of these wipes. The affected products are intended for urological use in the drainage, collection, and measurement of urine.
The recall involves 364 units distributed worldwide, including nationwide distribution in the United States and in Bahrain, Canada, Costa Rica, Guatemala, Mexico, Saudi Arabia, and the United Arab Emirates. Specific lot numbers and UDI-DI codes for the affected trays are listed in the agency's recall record.
Consumers and healthcare facilities should stop using the affected products and contact C.R. Bard Inc. for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray System
- Manufacturer
- C.R. Bard Inc
- Hazard
- Affected units
- 364
Distribution
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