Z-0321-06

HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A

Name: Z-0321-06 HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A
Creator: Philips Medical Systems
Published: 2005-11-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-11-18 / Terminated / root cause: labeling and UDI

FDA source

Philips Medical Systems began a recall of HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A on 2005-11-18. The reason FDA records is "The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0321-06
Status: Terminated
Initiated: 2005-11-18
Posted: 2005-12-23
Terminated: 2006-07-12
Recalling firm: Philips North America LLC
Product: HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A
Product code: MLN Electrode, Electrocardiograph, Multi-Function
Reason for recall: The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Philips Medical sent the recall notification letter 11/30/05 via FedEx
Quantity in commerce: 253 CASES (5/CS)
Distribution: Nationwide Foreign: Australia, Canada, France, germany, Spain,, Sweden, Switzerland, UK
Product codes and lots: Lot Number : Y042005-1

Product code MLN

K003228Class IIIK-Defib/pace Multifuction Pediatric Electrode, Model Kdp-70AKatecho, Inc. / cleared 2000-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)