Z-0856-2022 Class II Terminated
FDA device recall Z-0856-2022 was initiated by SA3, LLC on February 21, 2022 and is designated Class II. Reason for recall: Due to failure of microbial testing for total aerobic microbial count (TAMC). The recall status is terminated (terminated May 15, 2024). Affected quantity: 156 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- February 21, 2022
- Termination Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 156 units
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).
Distribution Pattern
U.S. Nationwide distribution in the states of CA, FL and GA.
Code Information
Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A