16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

Reason: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Code information: REF:UDI-DI/Lot: FCL-174-00/B:00884450522196/I2362705, I2370091, I2370711, I2370712, I2377840, I2377841, I2391548, I2397290, I2415120, I2417400, I2417401, I2417402, I2428656, I2428657, I2428658, I2428659, I2469204, I2469205, I2469206, I2469207, I2473119, I2485668, I2485669, I2485670, I2485671, I2485672, I2485673, I2485674, I2485675, I2496785, I2496787, I2496790, I2516610, I2516611, I2516612, I2516613, I2516614, I2516615, I2539710, I2539711, I2539713, I2539714, I2539715, I2539717, I2561078, I2561079, I2561081, I2561082, I2573969, I2606642, I2606643, I2606644, I2606645, I2619459, I2621646, I2621647, I2621648, I2621649, I2621650, I2621651, I2621652, I2621653, I2642738, I2642739, I2642740, I2644031, I2644032, I2644033, I2644034, I2644036, I2661872, I2661873, I2661874, I2661875, I2661876, I2661877, I2708121, I2708122, I2708123, I2708124, I2720071, I2720074, I2720075, I2720076, I2720077, I2720078, I2720079, I2729938, I2729939, I2729940, I2729941, I2729942, I2729943, I2729944, I2729945, I2759253, I2759254, I2759255, I2759256, I2759257, I2759258, I2759260, I2759261, I2759268, I2759269, I2781492, I2781493, I2781494, I2781495, I2781496, I2781497, I2781498, I2781499, I2788883, I2788884, I2788885, I2788886, I2788887, I2788888, I2788889, I2788890, I2788891, I2788892, I2810292, I2810293, I2810294, I2810296, I2810297, I2841474, I2841475, I2849305, I2849306, I2854355, I2854356, I2854357, I2860217, I2860218, I2861568, I2861569, I2871785, I2871786, I2871787, I2883689, I2883691, I2890983, I2904247, I2904250, I2927630, I2927631, I2942563, I2942564, I2942565, I2942566, I2942567, I2942568, I2942569, I2942570, I2942571, I2942667, I2942669, I2988895, I2988896, I2988897, I3013245, I3013246, I3075993, I3075994, I3075995, I3075996, I3075997, I3083308, I3083309, I3083310, I3083312, I3083314, I3083317, I3098214, I3098256, I3127468, I3138237, I3138238, I3138239, I3138240, I3138241, I3138242, I3159773, I3159774, I3159776, I3159777, I3186218, I3257331

Distribution pattern: Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan