BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess PTA Balloon
FDA device recall Z-1533-2013 · posted 2013-06-12 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 415
- Distribution
- US Nationwide Distribution
- Date initiated
- 2013-05-28
- Date posted
- 2013-06-12
- Date terminated
- 2013-10-23
- Location
- Tempe, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACCESS PTA BALLOON DILATATION CATHETER (K073472) | C.R. Bard, Inc. | 2008-01-09 |