C.R. Bard Inc — Class II: Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone F
C.R. Bard Inc. initiated a Class II recall for multiple Foley and Intermittent Catheter Trays containing Pericare Wipes due to complaints of surface contamination on the wipes. The recall affects numerous product lines including Lubri-Sil, SureStep, and Bardex systems across various reference and UDI codes.
Facilities using C.R. Bard Foley and Intermittent Catheter Trays, clinical staff performing catheterization procedures, and quality management personnel responsible for device sterility and kitted component integrity.
Surface contamination on components within a sterile or procedural tray presents a risk of introducing pathogens during catheterization, potentially leading to urinary tract infections. This recall highlights the vulnerability of convenience kits where a failure in a single sub-component (the wipe) compromises the utility and safety of the entire catheterization system. Regulatory teams should monitor this as a signal of potential supply chain or sub-tier supplier quality issues.
QA teams should immediately verify inventory against the extensive list of affected REF and UDI codes for Foley and Intermittent Catheter Trays. Procurement and clinical departments should isolate affected trays and await further instructions regarding the disposal or return of contaminated Pericare Wipes components. Regulatory teams should review supplier quality agreements for kitted components to ensure adequate sterility and surface contamination controls.
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: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 10801741024938 00801741024948¿ 10801741024945 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray REF: 300416A UDI code: 00801741024580 10801741024587 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A300416A UDI code: 00801741073762¿ 10801741073769 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A303416A UDI code: 00801741073823 10801741073820 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A307416A A307418A UDI codes: 00801741104381¿ 10801741104388 00801741100505¿ 10801741100502 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897516 UDI code: 00801741073984 10801741073981 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray REF: A902416 UDI code: 00801741074042¿ 10801741074049 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray REF: A902418 UDI code: 00801741074059¿ 10801741074056 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter REF: A907316 UDI code: 00801741104749¿ 10801741104746 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942210 UDI code: 00801741100567¿ 10801741100564 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942212 UDI code: 00801741100536¿ 10801741100533 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942214 UDI code: 00801741074103¿ 10801741074100 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942216 UDI code: 00801741074110 10801741074117 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter REF: A947316 UDI code: 00801741074141 10801741074148 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942206 UDI code: 00801741100543 10801741100540 **** Lubri-Sil¿ I.C. Complete Care¿ Temp-Sensing Foley Catheter Tray and Urine Meter REF: 319516AM UDI code: 00801741024696¿ 10801741024693 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter REF: A119214M UDI code: 00801741073670¿ 10801741073677 REF: A119216M UDI code: 00801741073687 10801741073684 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter REF: A300916A UDI code: 00801741120862¿ 10801741120869 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516A UDI code: 00801741100338 10801741100335 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516AM UDI code: 00801741073892 10801741073899 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter REF: A900916A UDI code: 00801741121029¿ 10801741121026 SureStep" Foley Tray System Lubri-Sil¿ Temperature Sensing Foley Catheter REF: A909216M UDI code: 00801741104763¿ 10801741104760 ***** Bard¿ Urine Meter Foley Catheter Tray With Bard¿ Lubri-Sil¿ Catheter REF 942208 UDI code: 00801741029370 10801741029377 Bard¿ Urine Meter Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 942216 UDI code: 00801741024979 10801741024976 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray and Urine Meter REF: 303416A UDI code: 00801741024726 10801741024723 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter REF: A119218M UDI code: 00801741073694 10801741073691 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A300418A UDI code: 00801741073779 10801741073776 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A303418A UDI code: 00801741073830 10801741073837 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319514AM UDI code: 00801741073885 10801741073882 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942208 UDI code: 00801741100550 10801741100557 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942218 UDI code: 00801741074127 10801741074124 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley. Firm: C.R. Bard Inc (Covington GA United States). Status: Ongoing.
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