BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon recall: Labeling Error
BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are…
Why was BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon recalled?
Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.
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?
Product Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090
- Product
- BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are…
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 415
- Distribution
- US Nationwide Distribution
- Recall date
- June 19, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)