Recall Z-0998-2015 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Cordis Corporation
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.
| Date | Jan 16, 2015 (initiated Dec 22, 2014) |
| Status | Terminated |
| Reason | One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized. |
| Root cause | Labeling design |
| Action | 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 o |
| Quantity | 120 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121442 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Cordis Corporation, Jun 14, 2012 |