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E-LINE

Richard Wolf GmbH · Model 8426151 · UDI-DI 04055207017302

KNF

510(k) clearances

404

Adverse events

Recalls

Facilities

Description

WING ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 26/28 Fr, wing (flat loop profile), fork color white, stem color blue, PACK = 1 PC, for E-Line resectoscope, unsterile, reusable

Recalls

Date	Firm	Reason
2013-02-12	Integra LifeSciences Corp.	Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautio
2012-05-23	Integra Limited	The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
2009-12-01	LINA Medical ApS	Potential for the LiNA Loop to break during operating procedure.
2009-12-01	LINA Medical ApS	Potential for the LiNA Loop to break during operating procedure.
2009-12-01	LINA Medical ApS	Potential for the LiNA Loop to break during operating procedure.

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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.