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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 pack see related information
Date Initiated by Firm February 24, 2012
Date Posted July 02, 2013
Recall Status1 Terminated 3 on July 15, 2013
Recall Number Z-1652-2013
Recall Event ID 65410
510(K)Number K072008  
Product Classification Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
Product 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.
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 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.
FDA Determined
Cause 2		 Material/Component Contamination
Action Braemar began notifying customers by telephone on 2/24/2012. Braemar issued Advisory Notice letter P/N 600-066201 RevA on 3/02/2012. The letter described the product, the problem, and the action to be taken by the customer. Customers were requested to only use TESTED batteries that they have receivewd fromBraemar starting on February 23, 2012. Complete and return the attached Verification Form. If customers have any untested product in their inventory, they were instructed to segregate those battery packs and await further instruction from Braemar to coordinate the return of those untested units. Upon receipt of the attached verification form, Braemar will continue to send replacement battery packs that have passed the additional testing protocol. Customers were instructed to contact their Braemar sales representative if they have any questions regarding the notice. For questions regarding this recall call 651-286-8620.
Quantity in Commerce 3286 packs
Distribution Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DRG and Original Applicant = BRAEMAR, INC.
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