Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix recall
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Why was Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix recalled?
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
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?
Lot Number: KF1111796 Exp. Date: 11/30/2013
- Product
- Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
- Recalling firm
- Arrow International Inc
- Quantity
- 166 units
- Distribution
- Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
- Recall date
- March 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)