Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
Reason for recall: Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable). Distribution: Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, 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, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; OUS (foreign) countries of: Australia, Belgium, Canada, Hong Kong and Japan. O.U.S.: Australia, Belgium, Canada, Hong Kong, and Japan. Quantity: 7520 (Breakdown: US 3764; OUS 3243) Lot/code info: Catalog Numbers/Lot-Serial Numbers/UDI Code: 0601610 / REFX4541 / (01)00801741036385(17)230930(10)REFX4541 0601610 / REFX5636 / (01)00801741036385(17)240930(10)REFX5636 0601610 / REFY2820 / (01)00801741036385(17)230930(10)REFY2820 0601610 / REGP0198 / (01)00801741036385(17)241231(10)REGP0198 0601610 / REGP2720 / (01)00801741036385(17)250131(10)REGP2720 0601610 / REGQ1144 / (01)00801741036385(17)250228(10)REGQ1144 0601620 / REES0680 / (01)00801741074479(17)230430(10)REES0680 0601620 / REEU0726 / (01)00801741074479(17)230630(10)REEU0726 0601620 / REEU1536 / (01)00801741074479(17)230630(10)REEU1536 0601620 / REEU3300 / (01)00801741074479(17)230630(10)REEU3300 0601620 / REEV1906 / (01)00801741074479(17)230731(10)REEV1906 0601620 / REFX4543 / (01)00801741074479(17)230930(10)REFX4543 0601630 / REEQ0746 / (01)00801741036408(17)230228(10)REEQ0746 0601630 / REGN2382 / (01)00801741036408(17)241231(10)REGN2382 0601630 / REGQ1143 / (01)00801741036408(17)250228(10)REGQ1143 0601680 / REER3749 / (01)00801741036415(17)230331(10)REER3749 0601680 / REEU1626 / (01)00801741036415(17)230630(10)REEU1626 0601690 / REES0716 / (01)00801741036422(17)230131(10)REES0716 0601690 / REFX1172 / (01)00801741036422(17)230131(10)REFX1172 0601690 / REFY0874 / (01)00801741036422(17)230131(10)REFY0874 0601700 / REES2549 / (01)00801741036439(17)230430(10)REES2549 0601700 / REGQ1154 / (01)00801741036439(17)230731(10)REGQ1154 0601710 / REFY2852 / (01)00801741036446(17)231031(10)REFY2852 0601730 / REGQ1174 / (01)0080
00801741036385, 00801741074479, 00801741036408, 00801741036415, 00801741036422, 00801741036439, 00801741036446, 00801741036453, 00801741036460, 00801741036477, 00801741036484, 00801741036514, 00801741036798, 00801741036804, 00801741036378
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.