Recall Z-1652-2013 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
BRAEMAR, INC.
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.
| Date | Jul 2, 2013 (initiated Feb 24, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 3286 packs |
| Distribution | Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072008 | BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER Braemar, Inc., Oct 3, 2007 |