Cordis SABER PTA Balloon Dilation Catheter recall: Foreign Material
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Why was Cordis SABER PTA Balloon Dilation Catheter recalled?
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
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/Batch number 82219442
- Product
- Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
- Recalling firm
- Cordis Corporation
- Quantity
- 8 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)