C.R. Bard Inc — Class II: Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Cathete
C.R. Bard Inc has initiated a Class II recall for specific SureStep Foley and Intermittent Catheter Tray systems due to reports of visible contamination on the surface of the included Pericare wipes. The recall is currently listed as ongoing and affects multiple reference numbers and UDI codes for trays used in urine drainage and collection.
This recall affects C.R. Bard Inc, healthcare facilities utilizing SureStep Foley Tray Systems, and professionals in Quality Assurance, Clinical Operations, and Supply Chain responsible for urological device inventory and patient safety.
The presence of surface contamination on wipes intended for perineal care during catheterization poses a potential risk of introducing pathogens to the urinary tract. For regulatory professionals, this underscores the vulnerability of convenience kits where a single contaminated component can compromise the entire sterile field or procedure tray. The classification as Class II suggests the FDA considers the health risk to be moderate or temporary, but the 'ongoing' status necessitates immediate inventory reconciliation.
Quality teams should verify if any affected SureStep Foley or Intermittent Catheter Trays are in inventory and sequester them according to the firm's recall instructions. Procurement and clinical departments should identify alternative urological drainage supplies if current stock is impacted by this ongoing recall. QA should review supplier quality agreements for any third-party components, such as wipes, included in convenience kits.
Class II. Reason: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.. 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" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369¿ 10801741100366 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915¿ 10801741073912 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097¿ 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.. Firm: C.R. Bard Inc (Covington GA United States). Status: Ongoing.
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