Recall Z-0785-2016— Bard Peripheral Vascular Inc

Name: FDA recall Z-0785-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-05

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2016-01-05, terminated 2016-03-25. It names one FDA 510(k) clearance: K983861. Product: Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.. Reason: Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2016-01-05
Terminated: 2016-03-25
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K983861 — DISTAFLO BYPASS GRAFTImpra, Inc.·cleared 1998-11-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.