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Recall Observatory FDA recall evidence

Device product

Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.

Z-0785-2016

January 05, 2016

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 73022
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-0785-2016

Official wording

Reason: Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.

Code information: Product Code: DF6006SC Lot Number: VTZE1782

Distribution pattern: Distributed in the states of AL, TX, and CA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeling