C.R. Bard Inc: 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

Is my product affected?

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

• UPC 00801741024924
• UPC 10801741024921
• UPC 00801741024931
• UPC 10801741024938
• UPC 00801741024948
• UPC 10801741024945
• UPC 00801741024580
• UPC 10801741024587
• UPC 00801741073762
• UPC 10801741073769
• UPC 00801741073823
• UPC 10801741073820
• UPC 00801741104381
• UPC 10801741104388
• UPC 00801741100505
• UPC 10801741100502
• UPC 00801741073984
• UPC 10801741073981
• UPC 00801741074042
• UPC 10801741074049
• UPC 00801741074059
• UPC 10801741074056
• UPC 00801741104749
• UPC 10801741104746
• UPC 00801741100567
• UPC 10801741100564
• UPC 00801741100536
• UPC 10801741100533
• UPC 00801741074103
• UPC 10801741074100
• UPC 00801741074110
• UPC 10801741074117
• UPC 00801741074141
• UPC 10801741074148
• UPC 00801741100543
• UPC 10801741100540
• UPC 00801741024696
• UPC 10801741024693
• UPC 00801741073670
• UPC 10801741073677

Check against the official notice below — it lists the full affected range.

Hazard

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

Details from the source

Reason for recall: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Costs Rica, Guatemala, Mexico, Saudi Arabia, and United Arab Emirates. Quantity: 283883 trays/kits 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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