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U.S. Department of Health and Human Services

Class 2 Device Recall Lithium Thionyl nonrechargeable disposable battery pack

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 Class 2 Device Recall Lithium Thionyl nonrechargeable disposable battery packsee related information
Date Initiated by FirmMay 02, 2011
Date PostedJuly 02, 2013
Recall Status1 Terminated 3 on July 15, 2013
Recall NumberZ-1645-2013
Recall Event ID 65423
510(K)NumberK072008 
Product Classification Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
ProductLithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
Code Information n/a
Recalling Firm/
Manufacturer		 BRAEMAR, INC.
1285 Corporate Center Dr
Eagan MN 55121-1267
For Additional Information Contact
651-286-8620
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionBraemar 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.
Quantity in Commerce10,785 packs
DistributionNationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DRG
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