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Terminated

1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); Cat No 1680-003 (3 units per pouch/30 per box); Cat No 1680-005 (5 units per pouch/50 per box); and Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case. Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York

FDA Recall Z-1184-03 · Posted 2003-08-27

Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeDRX
Date Initiated2003-07-30
Date Terminated2005-03-21
Product Quantity200,412 electrodes (# corrected 9/5/03)

Reason for Recall

Separation of the sensing element from the body of the electrode.

Firm Action

Letters dated 7/30/03 requesting return of recalled lots and subrecall by distributors.

Root Cause

Other

Distribution Pattern

241 direct accounts including wholesalers and medical facilities. Of these, there are 15 foreign consignees in Canada, Belgium, Germany, Norway, The Netherlands, Spain, United Kingdom, Japan, Malaysia, Thailand, and United Arab Emirates .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991105ECG ELECTRODE (VARIOUS)Conmedcorp · 1999-11-26

Official Source

View FDA Recall →

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

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