Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.
FDA Recall Z-1242-06 · Posted 2006-07-28
Advertisement
Recalling FirmKimberly-Clark Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2006-05-18
Date Terminated2007-05-14
Product Quantity95,639 electrode sets
Reason for Recall
The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation.
Firm Action
Consignees were first contacted by phone with follow up letter sent via fax or mail on May 18, 2006. International consignees will be notified through the firm's regional offices.
Root Cause
Device Design
Distribution Pattern
Worldwide ( including USA, Switzerland, Germany, UK, Canada, Australia, Netherlands, Italy, Greece, Spain, Hong Kong, Hungary, Denmark, Singapore, New Zealand, Ireland, Korea)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement