FDA Recall
Terminated
HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A
Recall: Z-0321-06
·
Initiated November 18, 2005
Recall
- Recall Number
- Z-0321-06
- Event Number
- 34045
- Firm
- Philips Medical Systems
- FEI Number
- 1218950
- Product Code
- MLN
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 18, 2005
- Posted
- December 23, 2005
- Terminated
- July 12, 2006
- Address
- 3000 Minuteman Road, Andover, MA, 01810-1032
Description
HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A
Reason
The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector
Action
Philips Medical sent the recall notification letter 11/30/05 via FedEx
Distribution
Nationwide Foreign: Australia, Canada, France, germany, Spain,, Sweden, Switzerland, UK
Quantity
253 CASES (5/CS)