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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device REF 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.
Recall Number Z-0740-2013
Classification Class II
Code Info 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.
Product Distributed Qty 98,675 units distributed in US.
Reason For Recall On 10/29/2012 Cordis Corporation, Miami Lakes, FL initiated a recall of their Cordis ExoSeal (TM) Vascular Closure Device. Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700.

Event Detail

Event Id 63827
Product Type Devices
Status Ongoing
Recalling Firm Cordis Corporation
City Miami Lakes
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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