Recall Z-2109-2021 ยท KGN Wound Dressing With Animal-Derived Material(S)
Southwest Technologies Inc
Stimulen Collagen Moisturizing Lotion, ST9555B
| Date | May 28, 2021 |
| Status | Open, Classified |
| Reason | Dose audit failure after sterilization process |
| Root cause | Under Investigation by firm |
| Action | The firm notified its sold consignee of the issue by telephone on 05/28/2021 of the issue. The firm followed with a letter disseminated by letter on 06/18/2021 requesting that the distributor destroy any product on hand and notify their customers. |
| Quantity | 2016 units |
| Distribution | Malaysia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030774 | STIMULEN COLLAGEN Southwest Technologies, Inc., Aug 9, 2004 |