Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, ...
FDA Device Recall #Z-0740-2013 — Class II — October 29, 2012
Recall Summary
| Recall Number | Z-0740-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 29, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cordis Corporation |
| Location | Miami Lakes, FL |
| Product Type | Devices |
| Quantity | 98,675 units distributed in US. |
Product Description
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.
Reason for Recall
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.
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.
Lot / Code Information
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.
Other Recalls from Cordis Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0221-2022 | Class II | SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ F... | Oct 1, 2021 |
| Z-0216-2022 | Class II | SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex... | Oct 1, 2021 |
| Z-0220-2022 | Class II | SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Fl... | Oct 1, 2021 |
| Z-0218-2022 | Class II | SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Fl... | Oct 1, 2021 |
| Z-0219-2022 | Class II | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex... | Oct 1, 2021 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.