🍔 Food 💊 Drugs 🏥 Medical Devices
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. Class I

Reason: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.

Hospira Inc. 20130318 Terminated
Distributed: Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
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GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. Class I

Reason: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.

Hospira Inc. 20130318 Terminated
Distributed: Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
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CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. Class II

Reason: There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

Trophy Sas 20120918 Terminated
Distributed: USA Nationwide Distribution
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CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. Class II

Reason: There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

Trophy Sas 20120918 Terminated
Distributed: USA Nationwide Distribution
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CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. Class II

Reason: There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

Trophy Sas 20120918 Terminated
Distributed: USA Nationwide Distribution
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CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. Class II

Reason: There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

Trophy Sas 20120918 Terminated
Distributed: USA Nationwide Distribution
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The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Class II

Reason: The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.

Alere San Diego, Inc. 20130306 Terminated
Distributed: USA Nationwide Distribution
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ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. Class II

Reason: The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six

DePuy Mitek, Inc., a Johnson & Johnson Co. 20130322 Terminated
Distributed: Nationwide Distribution.
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ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. Class II

Reason: The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six

DePuy Mitek, Inc., a Johnson & Johnson Co. 20130322 Terminated
Distributed: Nationwide Distribution.
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ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. Class II

Reason: The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six

DePuy Mitek, Inc., a Johnson & Johnson Co. 20130322 Terminated
Distributed: Nationwide Distribution.
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