Reported Feb 6, 2013 · Terminated
Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used…
Cordis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis Corporation · 14201 Nw 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- 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.
- Lot codes and dates
- Model EX500
Lot #'s: 154109061541165915424968154290981542987915437509154379581544420815449422154535401545656715456568154627791546278015469984154791991548134115485491154899701550195515505186155787091558936815586530156021991560336915608590156108011561754815630141156301711563938815642692156486621565092315656441156640831567035115670768
- Model EX600
90 of 90 codes
Lot #'s: 154086061540933215410622154106231542689015430798154330951543309815441594154433271544606315448005154515421545298715455770154557711545936615459367154611791546178115463296154632971546429815464299154663621547204415475128154757951547964415484135154874581549173715496311154970381550007815500709155030151550422315504224155047481550692615508012155083531550885615510541155127131551823215540529155450671554855515549324155501961555019715557284155615451556154615566744155721851557348015579468
- Model EX500
- Amount recalled
- 98,675 units distributed in US.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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