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Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. Class II

Reason: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Covidien LP 20130506 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela
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Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. Class II

Reason: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Covidien LP 20130506 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela
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Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. Class II

Reason: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Covidien LP 20130506 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela
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Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital. Class II

Reason: Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.

Hill-Rom, Inc. 20130415 Terminated
Distributed: Worldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands, Pakistan, panama, Paraguay, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, United States, US Virgin Islands, Venezuela and Vietnam.
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Active Articulation E1. Intended for use with either primary or revision hip arthroplasty. Class II

Reason: Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.

Biomet, Inc. 20130426 Terminated
Distributed: Distributed in New York.
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da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments Class II

Reason: Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).

Intuitive Surgical, Inc. 20130506 Terminated
Distributed: Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
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da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments, Class II

Reason: Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).

Intuitive Surgical, Inc. 20130506 Terminated
Distributed: Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
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Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system. Class I

Reason: Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the

Symbios Medical Products, LLC 20130510 Terminated
Distributed: US Nationwide distribution.
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Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system. Class I

Reason: Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the

Symbios Medical Products, LLC 20130510 Terminated
Distributed: US Nationwide distribution.
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Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system. Class I

Reason: Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the

Symbios Medical Products, LLC 20130510 Terminated
Distributed: US Nationwide distribution.
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