CLASS II Device recall · Reported 10 Jul 2013 · FDA Enforcement Report

Lithium Thionyl non-rechargeable disposable battery pack recalled

Braemar is recalling Lithium Thionyl non-rechargeable disposable battery pack, distributed nationwide in the US. The recall was initiated on 24 Feb 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesn/a

Quantity recalled3286 packs

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-1652-2013
FDA event ID: 65410
Recalling firm: Braemar, Eagan, MN
Classification: Class II
Status: Terminated
Recall initiated: 24 Feb 2012
FDA classified: 2 Jul 2013
Reported: 10 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

24 Feb 2012	Recall initiated by company
2 Jul 2013	Classified by FDA	+494 days
10 Jul 2013	Published in enforcement report	+8 days

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

Reason for recall

Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

Where it was distributed

Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.

Nationwide Florida Illinois Massachusetts Minnesota New York Ohio Pennsylvania Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

n/a

Where was it sold?

Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.

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

More recalls from Braemar

All 2

Reported	Class	Recall	Company	Reason	Where
10 Jul 2013Device	CLASS II	Lithium Thionyl non-rechargeable disposable battery pack recalled	Braemar	Device Malfunction	Nationwide

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