Fisherbrand Sterile Swabs Recalled Due to Non-Pathogenic Organisms
Fisher Scientific is recalling Fisherbrand Sterile Swabs after customer complaints reported non-pathogenic organisms in two lots.
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. The hazard involves non-pathogenic organisms, which are not disease-causing, and the recall of the second lot is precautionary, fitting the criteria for moderate severity.
Plain-English summary
Fisher Scientific Co is recalling Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped, Wood Applicator Swabs. The recall involves 1,230 units distributed nationwide and in Canada. The specific product code is # 14-959-81, with affected lots #61513 and #8710, both having an expiration date of 2014-08.
The recall was initiated due to four customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513, and lot 8710 is being recalled as a precautionary measure. These swabs are used in applying medications to or taking specimens from a patient.
Consumers and healthcare facilities should stop using the affected lots and contact Fisher Scientific for instructions on return or replacement.
The recalled product
- Product
- Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.
- Manufacturer
- Fisher Scientific Co
- Category
- Medical Device — Swabs
- Hazard
- Affected units
- 1,230
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 (5)
- Product code # 14-959-81
- lot #61513
- expiration date: 2014-08
- and lot 8710
- expiration date 2014-08.
Distribution
Distributed nationwide across the United States.
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