The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1844-2015·Announced 2015-07-01

Volcano PV .035 Catheter Recalled for Incorrect Shelf Life Labeling

Volcano Corporation is recalling 162 PV .035 Catheters because they were labeled with incorrect shelf life dates during a relabeling procedure.

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, but the hazard is a minor labeling error regarding shelf life dates without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Volcano Corporation is recalling 162 units of the Volcano PV .035 Catheter (Part number 88901, Lot number 50002518). The device is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The recall involves products distributed nationwide in the United States and to one account in Canada.

The recall was initiated because, during a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling rather than the original shelf life date at the time of manufacture. This labeling error may result in the use of devices past their intended expiration date.

Healthcare providers and facilities that have received these devices should stop using them and contact Volcano Corporation for further instructions on how to return or dispose of the affected units.

The recalled product

Product
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to…
Manufacturer
Volcano Corporation
Category
Medical Device — Vascular Imaging
Hazard
Affected units
162

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 (2)

  • Product number 88901
  • lot number 50002518

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Volcano Corporation 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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