The Recall Desk
HighFDA (Devices)·Z-2109-2021·Announced 2021-07-28

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.

What this means for you

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
Category
Medical Device — Topical Moisturizer
Hazard
  • sterilization-audit-failure

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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