Flexor RTPS Guiding Sheath Product Usage: The Flexor recall
Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end…
Why was Flexor RTPS Guiding Sheath Product Usage: The Flexor recalled?
Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.
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?
Product Number: KCFW-10.0-35-RB-RTPS-100, Catalog Number G13081
- Product
- Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end…
- Recalling firm
- Cook Inc.
- Quantity
- 661
- Distribution
- Worldwide Distribution - US Nationwide in the state of: AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada and EU.
- Recall date
- July 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)