Recall Z-2109-2021— Southwest Technologies Inc

Name: FDA recall Z-2109-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-28

Class II · Ongoing

Class II FDA medical device recall by Southwest Technologies Inc, initiated 2021-05-28. It names one FDA 510(k) clearance: K030774. Product: Stimulen Collagen Moisturizing Lotion, ST9555B. Reason: Dose audit failure after sterilization process.

Recalling firm: Southwest Technologies Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-05-28
Firm location: Kansas City, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K030774 — STIMULEN COLLAGENSouthwest Technologies, Inc.·cleared 2004-08-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Stimulen Collagen Moisturizing Lotion, ST9555B

Reason for recall

Dose audit failure after sterilization process

Data sourced from openFDA. This site is unofficial and independent of the FDA.