Recall Z-2719-2016— Advanced Medical Solutions Ltd.

Name: FDA recall Z-2719-2016
Creator: U.S. Food and Drug Administration
Published: 2015-01-15

Class II · Terminated

Class II FDA medical device recall by Advanced Medical Solutions Ltd., initiated 2015-01-15, terminated 2016-11-23. It names one FDA 510(k) clearance: K090453. 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.. 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

510(k) clearances named in this recall

1 on FDA's record

K090453 — SILVER ALGINATE 11 WOUND DRESSINGAdvanced Medical Solutions Limited·cleared 2009-02-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.