CLASS II Device recall · Reported 17 Feb 2016 · FDA Enforcement Report

Bard Distaflo Vascular Bypass Graft recalled by Bard Peripheral Vascular

Bard Peripheral Vascular is recalling Bard Distaflo Vascular Bypass Graft, distributed in Alabama, California, Texas. The recall was initiated on 5 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: DF6006SC Lot Number: VTZE1782

Quantity recalled4 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0785-2016
FDA event ID: 73022
Recalling firm: Bard Peripheral Vascular, Tempe, AZ
Classification: Class II
Status: Terminated
Recall initiated: 5 Jan 2016
FDA classified: 9 Feb 2016
Reported: 17 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

5 Jan 2016	Recall initiated by company
9 Feb 2016	Classified by FDA	+35 days
17 Feb 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Distributed in the states of AL, TX, and CA.

Alabama California Texas

Questions about this recall

Is Bard Distaflo Vascular Bypass Graft recalled?

Yes. Bard Peripheral Vascular recalled Bard Distaflo Vascular Bypass Graft on 5 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-0785-2016.

Why was it recalled?

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

Which lots are affected?

Product Code: DF6006SC Lot Number: VTZE1782

Where was it sold?

Distributed in the states of AL, TX, and CA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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