SA3, LLC: Medical Device Recall in 2022 - (Recall #: Z-0856-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 21, 2022

Date Posted: April 13, 2022

Recall Number: Z-0856-2022

Event ID: 89687

Reason for Recall:

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

Status: Terminated

Product Quantity: 156 units

Code Information:

Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A

Distribution Pattern:

U.S. Nationwide distribution in the states of CA, FL and GA.

Voluntary or Mandated:

Voluntary: Firm initiated