Recall Z-1533-2013 ยท DQY Catheter, Percutaneous
Bard Peripheral Vascular Inc
BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatatio
| Date | Jun 12, 2013 (initiated May 28, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Mixed-up of materials/components |
| Action | BARD sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated May 30, 2013 via FedEx overnight with proof of delivery notice to all affected customers. The letter identified the affected product, reason for recall, actions to be taken, and contact information. Customers were instructed to complete the enclosed Recall and Effectivenss Check Form and fax to the attention of Recall Coordinator in Customer Service at 1-800-994-6772. |
| Quantity | 415 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073472 | VACCESS PTA BALLOON DILATATION CATHETER C.R. Bard, Inc., Jan 9, 2008 |