ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is pa...

FDA Device Recall #Z-2720-2016 — Class II — January 15, 2015

Recall Summary

Recall Number Z-2720-2016
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 29,204 cartons

Product Description

ReliaMed¿ 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

OH

Lot / Code Information

51593 51772 52013 52001 52074 52668 52752 52756 52810 52851 53233 53234 53467 53655 53727 53685 53769 01129 01332 01569 02390 02584 02429 03696 03813 04095 04137

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-2719-2016 Class II ReliaMed¿ Silver Alginate/CMC. Each dressing is... 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.