BRAEMAR, INC.: Medical Device Recall in 2013 - (Recall #: Z-1645-2013)

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 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

Product Classification:

Class II

Date Initiated: May 2, 2011

Date Posted: July 10, 2013

Recall Number: Z-1645-2013

Event ID: 65423

Reason for Recall:

Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related injury or present any clinical impact.

Status: Terminated

Product Quantity: 10,785 packs

Code Information:

n/a

Distribution Pattern:

Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated