Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P d
FDA device recall Z-1171-2009 · posted 2009-04-07 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDD
- Quantity affected
- TOTAL: 3218 units; 2052 in the US, 1166 internationally
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-02-16
- Date posted
- 2009-04-07
- Date terminated
- 2011-08-17
- Location
- Redmond, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR (K881153) | Physio-Control Corp. | 1988-07-27 |