Recalls / —
—#42988
Product
HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A
- FDA product code
- MLN — Electrode, Electrocardiograph, Multi-Function
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K003228
- Affected lot / code info
- Lot Number : Y042005-1
Why it was recalled
The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector
Root cause (FDA determination)
Other
Action the firm took
Philips Medical sent the recall notification letter 11/30/05 via FedEx
Recalling firm
- Firm
- Philips Medical Systems
- Address
- 3000 Minuteman Road, Andover, Massachusetts 01810-1032
Distribution
- Distribution pattern
- Nationwide Foreign: Australia, Canada, France, germany, Spain,, Sweden, Switzerland, UK
Timeline
- Recall initiated
- 2005-11-18
- Posted by FDA
- 2005-12-23
- Terminated
- 2006-07-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #42988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.