ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch...
FDA Device Recall #Z-2719-2016 — Class II — January 15, 2015
Recall Summary
| Recall Number | Z-2719-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 15, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Advanced Medical Solutions Ltd. |
| Location | Winsford |
| Product Type | Devices |
| Quantity | 47,569 cartons |
Product Description
ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
Reason for Recall
On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse
Distribution Pattern
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Lot / Code Information
AMS Lot number 51594 51800 51883 51928 52023 52024 52002 52065 52230 52750 52754 52782 52775 52811 53213 53488 53532 53628 53665 53633 53981 53989 54066 01334 01263 01341 02112 02438 02583 02592 02582 02523 03138 03667 03675 03819 03908 03779 04254 04142 05996 06086 06256
Other Recalls from Advanced Medical Solutions Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0619-2025 | Class II | MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X... | Oct 1, 2024 |
| Z-0617-2025 | Class II | Hollister CalciCare Calcium Alginate Dressing R... | Oct 1, 2024 |
| Z-0618-2025 | Class II | McKesson Calcium Alginate Dressing MFR# 3562 ... | Oct 1, 2024 |
| Z-2720-2016 | Class II | ReliaMed¿ Alginate/CMC. Each dressing is packe... | Jan 15, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.