Z-2720-2016Class II

ReliaMed Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a...

Name: Z-2720-2016 ReliaMed Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a...
Creator: Advanced Medical Solutions Ltd.
Published: 2015-01-15
License: https://open.fda.gov/license/

Advanced Medical Solutions Limited / initiated 2015-01-15 / Terminated / root cause: packaging

FDA source

Advanced Medical Solutions Ltd. began a recall of ReliaMed Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple... on 2015-01-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2720-2016
Classification: Class II
Status: Terminated
Initiated: 2015-01-15
Posted: 2016-09-02
Terminated: 2016-11-23
Recalling firm: Advanced Medical Solutions Limited
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.
Product code: FRO Dressing, Wound, Drug
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
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Advanced Medical Solutions' (AMS) Sole Customer has already received notification via telephone conference call, followed by emails and correspondence.
Quantity in commerce: 29,204 cartons
Distribution: OH
Product codes and lots: 51593 51772 52013 52001 52074 52668 52752 52756 52810 52851 53233 53234 53467 53655 53727 53685 53769 01129 01332 01569 02390 02584 02429 03696 03813 04095 04137

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2720-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2719-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02
Z-2720-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02

Product code FRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)