Stimulen Collagen Moisturizing Lotion recalled for sterilization audit failure
Southwest Technologies Inc is recalling Stimulen Collagen Moisturizing Lotion, ST9555B (Lot 2104007) due to failure in the sterilization audit process. Approximately 2016 units were distributed to Malaysia.
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: This is an FDA Class II recall for a topical medical device with a sterilization validation failure. The recall addresses a risk-of-harm product without reported injury, meeting the rubric criterion for severity score 3.
Plain-English summary
Southwest Technologies Inc is recalling Stimulen Collagen Moisturizing Lotion, ST9555B (Lot 2104007, expiration 02/2024) due to a dose audit failure following sterilization.
The recall affects approximately 2016 units distributed to Malaysia. The failure involves validation of the sterilization dose, which verifies that the product has been adequately sterilized for safety.
Consumers and healthcare facilities with this product should cease use and contact Southwest Technologies Inc for return or disposal instructions.
The recalled product
- Product
- Stimulen Collagen Moisturizing Lotion, ST9555B
- Manufacturer
- Southwest Technologies Inc
- Affected units
- 2,016
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 (2)
- Lot 2104007
- EXP: 02/2024
Distribution
Distribution scope not specified by the agency.
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