BRAEMAR, INC.: Medical Device Recall in 2013 - (Recall #: Z-1652-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 24, 2012

Date Posted: July 10, 2013

Recall Number: Z-1652-2013

Event ID: 65410

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.

Status: Terminated

Product Quantity: 3286 packs

Code Information:

n/a

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated