Polarx Fit Short And Long Tip Cryoablation Balloon Catheter
Recall Summary Polarx FIT Short and Long Tip Cryoablation Balloon Catheters are being recalled in Canada due to labelling and packaging issues. This is a Class I recall, which means the product could cause serious harm or death. The affected devices were distributed across Canada.
- Product
- Polarx FIT Short and Long Tip Cryoablation Balloon Catheter
- Reason
- Labelling and packaging
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2024-10-15
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4bcfcf63-f344-4dc0-ace2-797ac3a4f739