Recall Z-1645-2013 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
BRAEMAR, INC.
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.
| Date | Jul 2, 2013 (initiated May 2, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| 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. |
| Quantity | 10,785 packs |
| Distribution | Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, 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 |