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U.S. Department of Health and Human Services

Class 2 Device Recall Silatrix Oral Gel (10g)

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  Class 2 Device Recall Silatrix Oral Gel (10g) see related information
Date Initiated by Firm February 21, 2022
Create Date April 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-0856-2022
Recall Event ID 89687
510(K)Number K202000  
Product Classification Oral wound dressing - Product Code OLR
Product Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Code Information Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A
Recalling Firm/
Manufacturer		 SA3, LLC
2317 Cotner Ave
Los Angeles CA 90064-1803
For Additional Information Contact Farbod Melamed
310-282-8086
Manufacturer Reason
for Recall		 Due to failure of microbial testing for total aerobic microbial count (TAMC).
FDA Determined
Cause 2		 Under Investigation by firm
Action On 02/21/2022, the firm emailed an Urgent Recall Notification to customers informing them that the recall has been initiated due to the affected lot's microbial testing results for total aerobic microbial count (TAMC exceeded specifications prior to expiry of the gel. Customer are instructed to: 1. Immediately examine your inventory and quarantine product subject to this recall. 2. Immediately discontinue use and distribution of the identified lot number. 3. To request a prepaid shipping label, complete and return the enclosed Customer Market Withdrawal Return Response Form via email at info@alexso.com or via fax at 888-502-1669. 4. If customer have further distributed this product to other wholesalers or pharmacies, please identify and notify them at once of this product market recall. The Recall notification and return response form should be include when notifying these customers. 5. Return the affected product to: Alexso, Inc. c/o Recall 2317 Cotner Ave Los Angeles, CA 90064 For any questions, contact the Recalling Firm at (888)-495-6078, Monday through Friday 9:00 AM to 5:00 PM PST or email at info@alexso.com. On 03/07/2022, the firm emailed an updated "URGENT: Medical Device Market Removal" letter which informs customers of the potential risks/harms/hazards associated with use of the affected products and added that it is recommended that physicians monitor their patents for potential adverse reactions and events as a result of use of the affected product.
Quantity in Commerce 156 units
Distribution U.S. Nationwide distribution in the states of CA, FL and GA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLR and Original Applicant = SA3, LLC
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