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Devices
WELCON Catheterization Tray
Model / Serial
Assembly ID UT70101002U and UT70101400U. Lot Numbers: 905184 (1999116), 905240 (2013784), 905306 (2022227), 906320 (2050130), 906326 (2050141), 907177 (2075692), 907229 (2079816), 909270 (2152734), 910007 (2165988), 910224 (2183856), 911074 (2205933), 912006 (2242897), 912245 (2265322), 1001328 (2299790), 1002197 (2324937), 1002350 (2342704), 1003055 (2346521), 1003163 (2362102), 1003337 (2376018), 1004331 (2412783), 1005322 (2447048), 1006195 (2473260), 1007028 (2494621), 1007132 (2505492), 1007365 (2521813), 1007374 (2521824), 1008200 (2521842), 1008272 (2548567), 1010125 (2609442), 1010211 (2619061), 1010379 (2635683), 1011117 (2653292), 1011242 (2662145), 905179 (1999111), 905304 (2022225), 906031 (2024204), 906034 (2024207), 906223 (2045289), 906317 (2050127), 906322 (2050137), 907174 (2075689), 907224 (2079809), 907410 (2096921), 909321 (2155644), 910002 (2165983), 910217 (2183849), 910315 (2193854), 910405 (2197500), 911071 (2205929), 911272 (2225075),912004 (2242895), 912242 (2265319), 912357 (2270548), 1001032 (2272542), 1001122 (2282233), 1001325 (2299787), 1002031 (2308780), 1002192 (2324932), 1002262 (2332074), 1002348 (2342702), 1003049 (2346515), 1003161 (2362100), 1003276 (2371680), 1003329 (2375786), 1003334 (2376015), 1003340 (2376022), 1004239 (2399012), 1004326 (2412777), 1005001 (2421350), 1005176 (2434535), 1005318 (2447043), 1006068 (2456705), 1006106 (2463036), 1006190 (2473255), 1006315 (2480387), 1007021 (2494612), 1007128 (2505486), 1007363 (2521808), 1007370 (2521819), 1008019 (2521827), 1008195 (2521834), 1009017 (2555280), 1009280 (2592199), 1009383 (2600148), 1010123 (2609440), 1010206 (2619056), 1010377 (2635681), 1011076 (2644159), 1011114 (2653289). Pack Lot #s: 35207, 35317, 35560, 35853, 35995, 36146, 36302, 36467, 36614, 36763, 36903, 37026, 37162, 37273, 37400, 37673, 37807, 35207 35317, 35560, 35853,35995, 35995-36146, 36146, 36302, 36467, 36614, 36763, 36614, 36614/36763, 36763, 36903, 37026, 37162, 37273, 37400, 37673, 37807.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.
Product Description
REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 || Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs
Manufacturer
Nurse Assist, Inc
1 Event
Recall of WELCON Catheterization Tray
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Manufacturer
Nurse Assist, Inc
Manufacturer Address
Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
Manufacturer Parent Company (2017)
Nurse Assist Inc.
Source
USFDA
Language
English
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