FIBERNET Embolic Protection System: Recommended Vessel recall
FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile…
Why was FIBERNET Embolic Protection System: Recommended Vessel recalled?
Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.
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?
US Model Number FBC350500190, lot number 1E029174; Internation Model number FBN350500190; lot 1E012912.
- Product
- FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile…
- Recalling firm
- Medtronic Vascular, Inc.
- Quantity
- 50 total, all sizes: 18 in US, 32 Internationally.
- Distribution
- Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.
- Recall date
- April 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)