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Terminated

Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065

FDA Recall Z-1380-04 · Posted 2004-08-18

Recalling FirmBio-Detek, Inc.
Recall StatusTerminated
Product CodeDRF
Date Initiated2004-07-30
Date Terminated2005-01-13
Product Quantity9.971 pairs

Reason for Recall

Pads may fail due to excessive corrosion of the electrode prior to the expiration date

Firm Action

Biotek notified Zoll Medical Corp Zoll notified their customers by letter dated 7/28/04. Users are requested to discard electrodes and return an acknowledgement form. Recalled product will be replaced.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915159PEDIATRIC MULTI-FUNCTION ELECTRODESZmi Corp. · 1992-02-07

Official Source

View FDA Recall →

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

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