SA3, LLC Recall 89687
Description: Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
SA3, LLC Recall 89687 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0856-2022 |
| Event ID | 89687 |
| Event Description | Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of CA, FL and GA. |
| Quantity | 156 units |
| Recall Reason | Due to failure of microbial testing for total aerobic microbial count (TAMC). |
| Device Classification | 20220413 |
| Device Code Info | Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A |
| Center Classification Date | 20220404 |
| Recall Initiation Date | 20220221 |
| Recalling Firm | SA3, LLC |
| Initial Notification | |
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