Z-0998-2015 Class II Terminated
FDA device recall Z-0998-2015 was initiated by Cordis Corporation on Dec 22, 2014 and is designated Class II. Reason for recall: One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized. The recall status is terminated (terminated Jul 9, 2015). Affected quantity: 120.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 28, 2015
- Initiation Date
- Dec 22, 2014
- Termination Date
- Jul 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120
Product Description
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.
Reason for Recall
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
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.
Code Information
Catalog 4400615X, demo lot 15617883
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0998-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026