Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for

FDA device recall Z-0740-2013 · posted 2013-01-25 · Terminated

Recall details

Recalling firm

Cordis Corporation

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.

Action taken

Cordis Corporation sent an "Urgent Medical Device Recall (Removal ) letter dated October 29, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately identify and set aside all product listed in a manner that ensures the affected product will not be used. A product recall response form was attached for customers to review, complete, sign and return the enclosed acknowledgement form directly to Cordis. For further questions please call (786) 313-2000.

Root cause

Material/Component Contamination

Status

Terminated

Product code

MGB

Quantity affected

98,675 units distributed in US.

Distribution

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,

Date initiated

2012-10-29

Date posted

2013-01-25

Date terminated

2013-11-06

Location

Miami Lakes, FL