Recall Z-2720-2016— Advanced Medical Solutions Ltd.
Class II · Terminated
Class II FDA medical device recall by Advanced Medical Solutions Ltd., initiated 2015-01-15, terminated 2016-11-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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.
- Recalling firm
- Advanced Medical Solutions Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-15
- Terminated
- 2016-11-23
- Firm location
- Winsford, United Kingdom
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.