Cordis POWERFLEX PRO PTA Dilatation Catheter Intended recall
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal…
Why was Cordis POWERFLEX PRO PTA Dilatation Catheter Intended recalled?
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog 4400615X, demo lot 15617883
- Product
- Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal…
- Recalling firm
- Cordis Corporation
- 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.
- Recall date
- January 28, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)