Recall of Sterile Specimen Containers Due to Packaging Defect
Covidien LLC is recalling 5,187,100 sterile specimen containers because a packaging defect compromised the sterility of the outer surface.
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, and the hazard is a packaging defect compromising surface sterility without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class II recall for the Covidien Precision Specimen Container, 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile (Item Code: 17099). The recall involves 5,187,100 units distributed nationwide and in Japan.
The recall was initiated because the sterility of the outer surface of the container was compromised due to a packaging defect. The affected lots include all lots starting with 3, 4, and 5, as well as all lots from 600586264X to 613480164X.
Healthcare facilities and consumers should stop using these containers and contact the recalling firm, Covidien LLC, for further instructions or a refund.
The recalled product
- Product
- Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
- Manufacturer
- Covidien LLC
- Affected units
- 5,187,100
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)
- All lots starting with 3
- 4
- 5 and all lots from 600586264X to 613480164X
Distribution
Distributed nationwide across the United States.
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