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.
FDA Recall Z-1645-2013 · Posted 2013-07-02
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Recalling FirmBRAEMAR, INC.
Recall StatusTerminated
Product CodeDRG
Date Initiated2011-05-02
Date Terminated2013-07-15
Product Quantity10,785 packs
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.
Firm Action
Braemar began notifying customers by telephone on 5/2/2011. Braemar issued Advisory Notice letter P/N 600-0662-00 RevA dated May 16, 2011. The letter was sent by UPS to all consignees.The letter described the problem and the product involved in the recall. Consignees were advised not to use the battery pack in the Braemar ER920W or Braemar Fusion device and requested consignees to complete and return the Verification Form.
For questions regarding this recall call 651-286-8620.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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