—#132222

Product

Cordis 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.

FDA product code: LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K121442
Affected lot / code info: Catalog 4400615X, demo lot 15617883

Why it was recalled

One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.

Root cause (FDA determination)

Labeling design

Action the firm took

The 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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Nationwide 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.

Timeline

Recall initiated: 2014-12-22
Posted by FDA: 2015-01-16
Terminated: 2015-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132222. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.