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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis POWERFLEX PRO PTA Dilatation Catheter

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 Class 2 Device Recall Cordis POWERFLEX PRO PTA Dilatation Cathetersee related information
Date Initiated by FirmDecember 22, 2014
Date PostedJanuary 16, 2015
Recall Status1 Terminated 3 on July 09, 2015
Recall NumberZ-0998-2015
Recall Event ID 70080
510(K)NumberK121442 
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
ProductCordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Code Information Catalog 4400615X, demo lot 15617883
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information ContactHal Baden
786-313-2365
Manufacturer Reason
for Recall		One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
FDA Determined
Cause 2		Labeling design
ActionThe firm, Cordis, sent an "URGENT MEDICAL DEVICE RECALL (Removal)" letter dated December 29, 2014 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately check their inventory to confirm they do not have any units from the demo lot in possession; identify and set aside any unit from the identified lot; review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form; return any affected product to Cordis; share this letter with others in your facility; contact any other facility that has been provided with units of POWERFLEX PRO product; maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice witn any affected product. For any physician with medical concerns, please contact the Cordis Endovascular Medical Information Line 877-DEVICES Monday through Friday from 9am-5pm. For questions related to the recall that are not adequately addressed in the letter, please contact the Cordis Field Action Coordinator Hal Baden at (786) 313-2365. For questions related to the Acknowledgement Form and its return, please contact Cordis QA at (786) 313-8730.
Quantity in Commerce120
DistributionNationwide Distribution: US including states of: CT, NJ, NY, PA, MD, VA, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, SD, IL, MO, KS, NE, LA, OK, TX, CO, UT, AZ, CA, OR, WA, AR, IN, MN, WY, ND, NV, MA, RI, NH, CT, DE, District of Columbia and Hawaii.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LIT
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