PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 14, 2016 Initiated: January 15, 2015 #Z-2719-2016

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

Details

Units Affected
47,569 cartons
Distribution
OH
Location
Winsford

Frequently Asked Questions

What product was recalled?
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.. Recalled by Advanced Medical Solutions Ltd.. Units affected: 47,569 cartons.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2719-2016.