Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Reported: February 17, 2016 Initiated: January 5, 2016 #Z-0786-2016
Product Description
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Reason for Recall
Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Details
- Recalling Firm
- Bard Peripheral Vascular Inc
- Units Affected
- 4 units
- Distribution
- Distributed in the states of AL, TX, and CA.
- Location
- Tempe, AZ
Frequently Asked Questions
What product was recalled? ▼
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.. Recalled by Bard Peripheral Vascular Inc. Units affected: 4 units.
Why was this product recalled? ▼
Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2016. Severity: Moderate. Recall number: Z-0786-2016.
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