Cardinal Health Prefilled Buffered 10% Formalin Recalled for Concentration Issues
Richard-Allan Scientific Company is recalling Cardinal Health Prefilled Buffered 10% Formalin because the formalin concentration may be outside specifications.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Richard-Allan Scientific Company is recalling 235 cases of Cardinal Health Prefilled Buffered 10% Formalin, Product Code C4320-450B, Lot Number 300403. This product is used to store and fixate tissue prior to grossing and histological examination.
The recall was initiated because the affected lots could have Neutral Buffered Formalin (NBF) concentrations that are lower or higher than the desired specifications. The product was distributed nationwide in the United States and in Canada.
This recall is classified as Class I by the U.S. Food and Drug Administration. Users should stop using the affected product and contact the recalling firm for instructions.
The recalled product
- Product
- Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
- Manufacturer
- Richard-Allan Scientific Company
- Hazard
- Affected units
- 235
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: C4320-450B Lot Number: 300403
Distribution
Part of a larger recall action
This product is one of 7 recalled by Richard-Allan Scientific Company 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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