The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0786-2016·Announced 2016-02-17

Bard Distaflo Vascular Bypass Graft Recalled for Size Mislabeling

Bard Peripheral Vascular Inc is recalling four units of the Bard Distaflo Vascular Bypass Graft because the product is mislabeled as 6 mm when it is actually 8 mm.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (size mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Bard Peripheral Vascular Inc is recalling four units of the Bard Distaflo Vascular Bypass Graft, Product Code DF8006SC, Lot Number VTZE1783. The recall is due to size mislabeling; the product is labeled as a 6 mm diameter graft, but the actual packaged product is an 8 mm graft.

The affected units were distributed in the states of Alabama, Texas, and California. The grafts are intended for the bypass or reconstruction of peripheral arterial blood vessels.

Healthcare providers and patients should stop using the affected units and contact Bard Peripheral Vascular Inc for further instructions.

The recalled product

Product
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Vascular Graft
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Code: DF8006SC Lot Number: VTZE1783

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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