HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A
FDA device recall Z-0321-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector
- Action taken
- Philips Medical sent the recall notification letter 11/30/05 via FedEx
- Root cause
- Other
- Status
- Terminated
- Product code
- MLN
- Quantity affected
- 253 CASES (5/CS)
- Distribution
- Nationwide Foreign: Australia, Canada, France, germany, Spain,, Sweden, Switzerland, UK
- Date initiated
- 2005-11-18
- Date posted
- 2005-12-23
- Date terminated
- 2006-07-12
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A (K003228) | Katecho, Inc. | 2000-12-14 |