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U.S. Department of Health and Human Services

Class 2 Device Recall Total Resources International First Aid Kits

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  Class 2 Device Recall Total Resources International First Aid Kits see related information
Date Initiated by Firm March 11, 2022
Create Date May 13, 2022
Recall Status1 Open3, Classified
Recall Number Z-1090-2022
Recall Event ID 89899
Product Classification First Aid Kit with drug - Product Code LRR
Product Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electrolyte Tablets under the Brand of Medique and Medi-Lyte, Product Code: M963.
Code Information Kit Item No./Lot/Expiration/Best if Used by Date: 01REF2621/19268-10 01REF2621/20085-10/3/31/22, 01REF2621/20274-05/8/31/22, 10OUT02086REV3/21026-04/8/31/22,
Recalling Firm/
Manufacturer		 Total Resources Intl
420 S Lemon Ave Ste A
City of Industry CA 91789-2956
For Additional Information Contact
909-594-1220
Manufacturer Reason
for Recall		 ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a Fluid Bed Drier exhaust system breach, which presents the possibility of cross-contamination where the potential contaminations are well known API's at well below efficacious dose levels.
FDA Determined
Cause 2		 Process control
Action On 03/11/22 recall notices were sent to customers who were asked to do the following: 1) Examine your inventory and quarantine product subject to recall, which is the ULTRAtab products inside the kits, not the kits themselves . 2) The recall is extending to the retail level. If affected product has been further distributed, identify your customers, and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification. 3) Complete and return the Recall Acknowledgement to the recalling firm acknowledging receipt and understanding of the recall notice and documenting affected product (inside the kits) disposition. Affected products that are on hand are either marked as destroyed or returned. Customers with additional questions are encouraged to contact the recalling firm at (855) 883-3080 or email recall@trikits.com Monday through Friday between 8:30 am to 3:30 pm (PST).
Quantity in Commerce 891
Distribution US: IL, PA, VA, AR, TX, IA, DE, GA, NY, LA, AL, IN, MI, MO, NC, KS, CO, AZ, OH, MS, CA, FL, WI, KY, UT, OR, NH, TN, NV, CT
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.
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