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Kirwan

KIRWAN SURGICAL PRODUCTS LLC · Model 30-5201AU · UDI-DI 00841019117552

HAM Prescription
1
510(k) clearances
59
Adverse events
3
Recalls
33
Facilities

Description

Disp. Monopolar Suction Coagulator w/Resectoscope Pin, 8" (20cm), 10 Fr., Ferrule Tip

Recalls

DateFirmReason
2012-12-27ConMed CorporationConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected
2003-07-16Valleylab, IncPads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
2003-07-16Valleylab, IncPads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.