Recall Z-0856-2022— SA3, LLC

Name: FDA recall Z-0856-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-21

Class II · Terminated

Class II FDA medical device recall by SA3, LLC, initiated 2022-02-21, terminated 2024-05-15. It names one FDA 510(k) clearance: K202000. Product: Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm. Reason: Due to failure of microbial testing for total aerobic microbial count (TAMC)..

Recalling firm: SA3, LLC
Classification: Class II
Status: Terminated
Initiated: 2022-02-21
Terminated: 2024-05-15
Firm location: Los Angeles, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K202000 — Silatrix Oral GelSa3, LLC·cleared 2020-11-20

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

Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

Reason for recall

Due to failure of microbial testing for total aerobic microbial count (TAMC).

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