The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1041-2016·Announced 2016-03-09

Volcano R-100 Sterile Equipment Covers Recalled for Incorrect Expiry Date Labeling

Volcano Corporation is recalling R-100 Sterile Equipment Covers because the outer shipping boxes may display incorrect expiry dates, although the inner product is correctly labeled.

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: This is a minor labeling error on the outer packaging where the inner product is correctly labeled, fitting the rubric for moderate severity.

Plain-English summary

Volcano Corporation has initiated a recall of Volcano R-100 Sterile Equipment Covers. The recall was identified because certain lot numbers of these sterile covers may have incorrect expiry dates printed on the outer shipping boxes. The individually wrapped inner product bears the correct expiry date.

The affected products are sterile equipment covers intended to cover equipment used in the sterile surgical field that cannot be sterilized. The recall involves 1,355 total units. The products were distributed nationwide in the United States and in Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay. The specific reference numbers for the affected lots are PBKGB and PBKBG-10 (10 pack), covering all lots.

Consumers and healthcare facilities should check the outer shipping boxes of their Volcano R-100 Sterile Equipment Covers for incorrect expiry dates. If the outer box date is incorrect, the product should be returned to the supplier or Volcano Corporation for replacement or refund. The inner product remains correctly labeled and sterile.

The recalled product

Product
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile…
Manufacturer
Volcano Corporation
Category
Medical Device — Surgical Drapes and Covers
Hazard
Affected units
1,355

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)

  • REF numbers: PBKGB and PBKBG-10 (10 pack): all lots

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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