life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
FDA Recall Z-0522-2008 · Posted 2008-01-26
Recalling FirmExocomm Tech Grp
Recall StatusTerminated
Product CodeMKJ
Date Initiated2007-09-03
Date Terminated2013-07-01
Product Quantity266 units
Reason for Recall
Marketed without a 510K
Firm Action
The original recall communication was sent out on 9/3/07 by Phoenix Solutions, a consultant to Battery Zone, as a Dear Valued Customer notice. A second recall communication, Urgent Device Recall Letter, was issued by Exxocom Technology Group dated 10/25, was sent out to all customer (even those who had returned product) on 11/5/07. Both communication were sent by first class mail, requesting return of batteries
Root Cause
PMA
Distribution Pattern
Worldwide-Batteries were distributed to dealers or distributors in CT, GA, MN, NC, NY, OH, OK, OR, PA and TN plus one Canadian Consignee
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.