Recall Z-0740-2013— Cordis Corporation
Class II · Terminated
Class II FDA medical device recall by Cordis Corporation, initiated 2012-10-29, terminated 2013-11-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Cordis Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-29
- Terminated
- 2013-11-06
- Firm location
- Miami Lakes, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.