The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1845-2015·Announced 2015-07-01

Volcano Prestige Plus J-Tip Wire Recalled for Incorrect Shelf Life Labeling

Volcano Corporation is recalling 162 Prestige Plus 185cm J-Tip pressure wires 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 labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Volcano Corporation is recalling 162 units of the Prestige Plus 185cm J-Tip pressure wire (Part number 9185J). The devices are indicated for use to measure pressure in blood vessels during diagnostic angiography and interventional procedures.

The recall was initiated because, during a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life based on the date of 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.

The affected products were distributed nationwide in the United States and to one account in Canada. The specific lot number is 50004551/005-060, with serial numbers ranging from 005 to 060. Healthcare facilities should stop using these devices and contact Volcano Corporation for further instructions.

The recalled product

Product
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure…
Manufacturer
Volcano Corporation
Category
Medical Device — Cardiovascular
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 (3)

  • Product number 9185J
  • lot number 50004551/005-060
  • serial numbers 005-060.

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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