Class II — Advanced Medical Solutions Ltd.
| Recalling firm | ADVANCED MEDICAL SOLUTIONS GROUP PLC |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | 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. |
| Quantity | 47,569 cartons |
| Distribution | OH |
| Initiated | 2015-01-15 |
| Classified | 2016-09-02 |
| Terminated | 2016-11-23 |
| Recall number | Z-2719-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Advanced Medical Solutions Ltd. (Z-2719-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75033/
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