Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit cont...
FDA Device Recall #Z-1090-2022 — Class II — March 11, 2022
Recall Summary
| Recall Number | Z-1090-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 11, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Total Resources Intl |
| Location | City of Industry, CA |
| Product Type | Devices |
| Quantity | 891 |
Product Description
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.
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.
Distribution Pattern
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
Lot / 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,
Other Recalls from Total Resources Intl
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1089-2022 | Class II | Total Resources International First Aid Kits, I... | Mar 11, 2022 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.