Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Even

FDA device recall Z-1652-2013 · posted 2013-07-02 · Terminated

Recall details

Recalling firm

BRAEMAR, INC.

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.

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

DRG

Quantity affected

3286 packs

Distribution

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

Date initiated

2012-02-24

Date posted

2013-07-02

Date terminated

2013-07-15

Location

Eagan, MN

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