CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report

ReliaMed¿ Alginate/CMC recalled by Advanced Medical Solutions

Advanced Medical Solutions is recalling ReliaMed¿ Alginate/CMC, distributed in Ohio. The recall was initiated on 15 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes51593 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

Quantity recalled29,204 cartons

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2720-2016
FDA event ID: 75033
Recalling firm: Advanced Medical Solutions, Winsford
Classification: Class II
Status: Terminated
Recall initiated: 15 Jan 2015
FDA classified: 2 Sep 2016
Reported: 14 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

15 Jan 2015	Recall initiated by company
2 Sep 2016	Classified by FDA	+596 days
14 Sep 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Ohio

Questions about this recall

Why was it 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 lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 75033

This product is part of a recall event; the main page for the event is ReliaMed¿ Silver Alginate/CMC recalled by Advanced Medical Solutions.

Reported	Class	Recall	Company	Reason	Where
14 Sep 2016	CLASS II	ReliaMed¿ Silver Alginate/CMC recalled by Advanced Medical Solutions	Advanced Medical Solutions	Packaging Defects	OH

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024Device	CLASS II	McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing recalled	Advanced Medical Solutions	Sterility	Nationwide
11 Dec 2024Device	CLASS II	Hollister CalciCare Calcium Alginate Dressing recalled	Advanced Medical Solutions	Sterility	Nationwide
11 Dec 2024Device	CLASS II	Medline Maxorb Extra Alginate Wound Dressing Square recalled	Advanced Medical Solutions	Sterility	Nationwide
14 Sep 2016Device	CLASS II	ReliaMed¿ Silver Alginate/CMC recalled by Advanced Medical Solutions	Advanced Medical Solutions	Packaging Defects	OH

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