Reported Feb 26, 2014 · Terminated
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel +…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿
- Excel System Product UsageIntended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently
- Lot codes and dates
- All unexpired lot numbers for CEM Nosecone Gatalouge No. C6623 and C6636 from 1/1/2010 to present. CEM" Nosecone, Catalogue No
- C6623
106 of 106 codes
108365510842191084398108439910844001084682108468310909371091712109171410917151093125109312610931281093129109347110938471094575109474010955871095873110023711002381101217110154711015481102069110207011025441102545110254611031021103392110344411034451103446110426411042651105065110506611050671110208111031111103481110349111047311104741110892111176011121821112808111280911131751113176111317711131781113662111411211146541114655
- C6636
215 of 215 codes
108421610842931084377108468010846811090123109012410901251090126109066010906611090826109139510914341091700109238810923891092390109239110923921093012109301310931301093131109347210934731093474109382410938251093826109382710947411095104109510510951061095414109541510954181095419110023911002401100241110122011012211102647110264811026491102650110265111031031103394110339511034371103848110385111039161103917110391911039201103921
- Amount recalled
- 17253 boxes
Where it was sold
- Nationwide
Why it was recalled
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
This product could cause temporary or reversible health problems — stop using it.
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