C.R. Bard Inc recalls Products that contain the Pericare Wipes: Bard¿ Foley Tray

Recalled 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

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Hazard / Issue

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 00801741024931¿ 10801741024938 Lot Numbers: NGKU0162 NGKU2507 947318 / 00801741024948¿ 10801741024945 Lot Numbers: NGKU2420 NGKU2865 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray 300416A / 00801741024580 10801741024587 Lot Numbers: NGKT1464 NGKU0129 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A300416A / 00801741073762¿ 10801741073769 Lot Numbers: NGKT3316 NGKU0946 NGKU0972 NGKU1747 NGKU1823 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A303416A / 00801741073823 10801741073820 Lot Numbers: NGKT2388 NGKT2495 NGKT3290 NGKT3303 NGKT3318 NGKU0949 NGKU0974 NGKU1749 NGKU2011 NGKU2036 NGKU2922 NGKV0359 NGKV0360 NGKV1433 NGKV1454 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A307416A / 00801741104381 10801741104388 Lot Number: NGKS3764 A307418A / 00801741100505 10801741100502 Lot Number: NGKT2453 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897516 / 00801741073984 10801741073981 Lot Numbers: NGKT3226 NGKU0841 NGKU0954 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray A902416 / 00801741074042¿ 10801741074049 Lot Numbers: NGKU0843 NGKU2016 NGKU2049 NGKU2887 NGKU2929 NGKU3049 NGKU3975 NGKU4043 NGKU4716 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray A902418 / 00801741074059¿ 10801741074056 Lot Number: NGKU0956 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter A907316 / 00801741104749¿ 10801741104746 Lot Number: NGKU0855 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942210 / 00801741100567¿ 10801741100564 Lot Number: NGKT2458 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942212 / 00801741100536¿ 10801741100533 Lot Number: NGKT3373 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray A942214 / 00801741074103¿ 10801741074100 Lot Number: NGKT3232 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray A942216 / 00801741074110 10801741074117 Lot Numbers: NGKT3366 NGKT3374 NGKT3375 NGKT3394 NGKT3395 NGKU0845 NGKU0856 NGKU0957 NGKU1003 NGKU1004 NGKU1757 NGKU1850 NGKU2021 NGKU2052 NGKU2890 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter A947316 / 00801741074141 10801741074148 Lot Numbers: NGKT2396 NGKT2416 NGKT2460 NGKT3368 NGKT3377 NGKU0846 NGKU0857 NGKU0958 NGKU1758 NGKU1851 NGKU2022 NGKU4047 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942206 / 00801741100543 10801741100540 Lot Number: NGKT3364 ***** Lubri-Sil¿ I.C. Complete Care¿ Temp-Sensing Foley Catheter Tray and Urine Meter 319516AM / 00801741024696¿ 10801741024693 Lot Number: NGKU1994 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter A119214M / 00801741073670¿ 10801741073677 Lot Number: NGKV0292 A119216M / 00801741073687 10801741073684 Lot Numbers: NGKS3759 NGKT1887 NGKT2383 NGKT2404 NGKT3314 NGKU0971 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter A300916A / 00801741120862¿ 10801741120869 Lot Number: NGKS4948 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516A / 00801741100338 10801741100335 Lot Number: NGKT1899 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516AM / 00801741073892 10801741073899 Lot Numbers: NGKS4850 NGKT0702 NGKT0768 NGKT1863 NGKT2391 NGKT2412 NGKT2455 NGKT3305 NGKU0978 NGKU1025 NGKU2925 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter A900916A / 00801741121029¿ 10801741121026 Lot Number: NGKS4959 SureStep" Foley Tray System Lubri-Sil¿ Temperature Sensing Foley Catheter A909216M / 00801741104763¿ 10801741104760 Lot Number: NGKT2394 ***** Bard¿ Urine Meter Foley Catheter Tray With Bard¿ Lubri-Sil¿ Catheter 942208 / 00801741029370 10801741029377 Lot Number: NGKW2677 Bard¿ Urine Meter Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter 942216 / 00801741024979 10801741024976 Lot Numbers: NGKW2822 NGKW2751 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray and Urine Meter 303416A / 00801741024726 10801741024723 Lot Numbers: NGKW3769 NGKW0682 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter A119218M / 00801741073694 10801741073691 Lot Number: NGKW0605 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A300418A / 00801741073779 10801741073776 Lot Number: NGKX3768 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A303418A / 00801741073830 10801741073837 Lot Numbers: NGKW1796 NGKV1455 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319514AM / 00801741073885 10801741073882 Lot Numbers: NGKW2687 NGKV2393 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942208 / 00801741100550 10801741100557 Lot Number: NGKV3560 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray A942218 / 00801741074127 10801741074124 Lot Number: NGKX4530 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter A947314 / 00801741074134 10801741074131 Lot Numbers: NGKW0616 NGKV4999 NGKV3635 NGKV2289

✅ What Should You Do?

1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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C.R. Bard Inc recalls Products that contain the Pericare Wipes: Bard¿ Foley Tray

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