ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (
FDA device recall Z-2719-2016 · posted 2016-09-02 · Terminated
Recall details
- Recalling firm
- Advanced Medical Solutions Ltd.
- 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
- Action taken
- Advanced Medical Solutions' (AMS) Sole Customer has already received notification via telephone conference call, followed by emails and correspondence.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 47,569 cartons
- Distribution
- OH
- Date initiated
- 2015-01-15
- Date posted
- 2016-09-02
- Date terminated
- 2016-11-23
- Location
- Winsford, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILVER ALGINATE 11 WOUND DRESSING (K090453) | Advanced Medical Solutions Limited | 2009-02-26 |