Kendall SCD Express Sterile Sleeves Recalled for Sterility Failure
COVIDIEN LLC is recalling Kendall SCD Express Sterile Sleeves (Thigh Length) because they were distributed without undergoing sterilization.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a sterile medical device being distributed without sterilization, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
COVIDIEN LLC is recalling Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736, Lot Number 83410S09D. The recall involves 25 units that were distributed to healthcare facilities in California, New Jersey, and Washington.
The product is being recalled because it does not meet sterility requirements. Specifically, the product was labeled as sterile but was distributed without undergoing sterilization prior to distribution.
Healthcare providers and consumers should stop using the affected product immediately. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
- Manufacturer
- COVIDIEN LLC
- Affected units
- 25
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)
- Lot Number 83410S09D
Distribution
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