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Terminated

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

FDA Recall Z-0321-06 · Posted 2005-12-23

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMLN
Date Initiated2005-11-18
Date Terminated2006-07-12
Product Quantity253 CASES (5/CS)

Reason for Recall

The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector

Firm Action

Philips Medical sent the recall notification letter 11/30/05 via FedEx

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Australia, Canada, France, germany, Spain,, Sweden, Switzerland, UK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003228K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70AKatecho, Inc. · 2000-12-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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