Volcano Sterile Equipment Covers Recalled for Incorrect Expiry Date Labeling
Volcano Corporation is recalling certain lots of 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 criteria for moderate severity.
Plain-English summary
Volcano Corporation is recalling certain lot numbers of Volcano R-100 Sterile Equipment Covers. The recall was initiated because the outer shipping boxes for these products may display an incorrect expiry date. 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 REF numbers 891BG and 891BG-10 (10 pack) across all lots. A total of 1,355 units were distributed.
The products were distributed in the United States (nationwide) and in Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay. Users should check the expiry date on the outer shipping box and the individually wrapped inner product to verify the correct date.
The recalled product
- Product
- Volcano SpinVision Sterile Equip cover II; 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…
- Manufacturer
- Volcano Corporation
- 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: 891BG and 891BG-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.
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