Recall Z-1171-2009 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Physio Control, Inc.
Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors.
| Date | Apr 7, 2009 (initiated Feb 16, 2009) |
| Status | Terminated |
| Reason | Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling. |
| Root cause | Other |
| Action | Recalling firm sent Urgent Medical Device Recall letters, dated 2/2009, advising customers to discontinue use of the listed sterilization methods and to remove them from service since there is no sterilization method that can be supported by current data. They are to use the enclosed form to identify and confirm if they have the listed products and follow the instructions on the form for returning information to the firm. |
| Quantity | TOTAL: 3218 units; 2052 in the US, 1166 internationally |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K881153 | LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR Physio-Control Corp., Jul 27, 1988 |