Bard Conquest PTA Balloon dilation Catheter recall: Labeling Error
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous…
Why was Bard Conquest PTA Balloon dilation Catheter recalled?
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.
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 No. REDU2646 Expiration Date: 06/30/2022
- Product
- Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous…
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 281 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of GA, AZ, MD, CA, VA, AR, TX, SD, NC, MO, WI, CO, FL, PA and the country of Taiwan.
- Recall date
- October 14, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)