cordis exoseal vascular closure device

Model: Models: EX500CE, EX600CE and EX700CE, Affected: All lot numbers from 15466779 to 15682751

Model EX500: Lot #'s: 15410906, 15411659, 15424968, 15429098, 15429879, 15437509, 15437958, 15444208, 15449422, 15453540, 15456567, 15456568, 15462779, 15462780, 15469984, 15479199, 15481341, 15485491, 15489970, 15501955, 15505186, 15578709, 15589368, 15586530, 15602199, 15603369, 15608590, 15610801, 15617548, 15630141, 15630171, 15639388, 15642692, 15648662, 15650923, 15656441, 15664083, 15670351, 15670768.  Model EX600: Lot #'s: 15408606, 15409332, 15410622, 15410623, 15426890, 15430798, 15433095, 15433098, 15441594, 15443327, 15446063, 15448005, 15451542, 15452987, 15455770, 15455771, 15459366, 15459367, 15461179, 15461781, 15463296, 15463297, 15464298, 15464299, 15466362, 15472044, 15475128, 15475795, 15479644, 15484135, 15487458, 15491737, 15496311, 15497038, 15500078, 15500709, 15503015, 15504223, 15504224, 15504748, 15506926, 15508012, 15508353, 15508856, 15510541, 15512713, 15518232, 15540529, 15545067, 15548555, 15549324, 15550196, 15550197, 15557284, 15561545, 15561546, 15566744, 15572185, 15573480, 15579468, 15585121, 15587184, 15596793, 15601234, 15601753, 15604477, 15605089, 15609335, 15613282, 15617549, 15625033, 15627316, 15635233, 15637262, 15643624, 15644116, 15644789, 15644790, 15649759, 15663330.  Model EX700 Lot #'s: 15466361, 15471271, 15471272, 15476317, 15476743, 15482155, 15483371, 15486224, 15490397, 15535011, 15540530.

Cardiovascular Devices

3

No

US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.

Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.

Cordis ExoSeal Vascular Closure Device (femoral artery compression device)Product Numbers: EX500CE, EX600CE, EX700CEAll lot numbers from 15466779 to 15682751ARTG Number: 176723