Home / Recalls / Southwest Technologies Inc / Z-2109-2021

Z-2109-2021 Class II Ongoing

Recalled by Southwest Technologies Inc — Kansas City, MO

FDA device recall Z-2109-2021 was initiated by Southwest Technologies Inc on May 28, 2021 and is designated Class II. Reason for recall: Dose audit failure after sterilization process The recall status is ongoing. Affected quantity: 2016 units.

Recall Details

Product Type
Devices
Report Date
July 28, 2021
Initiation Date
May 28, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2016 units

Product Description

Stimulen Collagen Moisturizing Lotion, ST9555B

Reason for Recall

Dose audit failure after sterilization process

Distribution Pattern

Malaysia

Code Information

Lot 2104007, EXP: 02/2024

Other recalls by Southwest Technologies Inc

  • Z-0687-2020 Class II — Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile (November 18, 2019)
  • Z-1602-2018 Class II — HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (December 28, 2017)
  • Z-1600-2018 Class II — HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) (December 28, 2017)
  • Z-1601-2018 Class II — HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a (December 28, 2017)

FDA data resources