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Terminated

Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.

FDA Recall Z-1122-03 · Posted 2003-08-12

Recalling FirmValleylab, Inc
Recall StatusTerminated
Product CodeHAM
Date Initiated2003-07-16
Date Terminated2004-02-18
Product Quantity10,000 kits

Reason for Recall

Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.

Firm Action

Users were notified by letter on 7/16/2003.

Root Cause

Other

Distribution Pattern

Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France, Germany, Hong Kong, India, Israel, Japan, Korea, Phillipines, Singapore, Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MNikomed U.S.A., Inc. · 2000-02-04

Official Source

View FDA Recall →

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

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