🍔 Food 💊 Drugs 🏥 Medical Devices
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4) 8F/SL/Plastic Port/F, Product Number H965450220, Catalog Number 45-022; 5) 8F/SL/Titanium Ports/F, Product Number H965450250, Catalog Number 45-025; 6) Plastic/6F/non-filled/non-valved, Product Number H965450290, Catalog Number 45-029; 7) Plastic/6F/filled/non-valved, Product Number H965450300, Catalog Number 45-030; 8) Plastic/8F/non-filled/non-valved, Product Number H965450310, Catalog Number 45-031; 9) Plastic/8F/filled/non-valved, Product Number H965450320, Catalog Number 45-032; 10) Plastic/6F/non-filled/valved, Product Number H965450370, Catalog Number 45-037; 11) Plastic/6F/filled/valved, Product Number H965450380, Catalog Number 45-038; 12) Plastic/8F/non-filled/valved, Product Number H965450390, Catalog Number 45-039; 13) Plastic/8F/filled/valved, Product Number H965450400, Catalog Number 45-040; 14) Titanium/6F/non-filled/valved, Product Number H965450410, Catalog Number 45-041; 15) Titanium/8F/non-filled/valved, Product Number H965450430, Catalog Number 45-043. Product Usage: ***K-Shield Port Access Infusion Set, (affected product) supplied by Kawasumi Laboratories. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port.***NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Class II

Reason: Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.

Navilyst Medical, Inc. 20131125 Terminated
Distributed: US Nationwide Distribution in the states of CA, CT, DC, MA, NJ, NY, PA, MD, VA, WV, NC, GA, FL, TN, OH, MN, MT, IL, MO, NE, OK, TX, NM, and WA.
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ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system. Class II

Reason: The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport.

Siemens Medical Solutions USA, Inc. 20131222 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Canada, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed. Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E., and United Kingdom.
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ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes. Class II

Reason: The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.

Siemens Medical Solutions USA, Inc. 20131222 Terminated
Distributed: Worldwide Distribution - US (nationwide) and the countries of Albania, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Brunei, Canada, Columbia, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Israel, Italy, Japan, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, Norway, Oman, P.R. China, Philippines, Poland, Qatar, Rep of Yemen, Republic Korea, Romania, Russian Fed. San Marino, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. United Kingdom and Venezuela.
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Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Class II

Reason: The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.

Philips Medical Systems (Cleveland) Inc 20110307 Terminated
Distributed: Worldwide Distribution - US Distribution including the states of DC, IL, IN, MI, MO, NY, OH, OR, PA, TX and VT., and the countries of Australia, Belgium, China, Germany, India, Israel, Italy and The Netherlands.
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Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures. Class II

Reason: Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.

Carestream Health Inc. 20130820 Terminated
Distributed: Nationwide Distribution including TX, IL, and GA.
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Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location. Class II

Reason: Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.)

Siemens Healthcare Diagnostics, Inc. 20131030 Terminated
Distributed: US Distribution in the states of: MN, NJ, and NV.
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Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients. Class II

Reason: Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.

Nellcor Puritan Bennett Inc. (dba Covidien LP) 20130125 Terminated
Distributed: Worldwide Distribution: US (nationwide) and Internationally to: Albania, Argentina, Australia, Bahrain, Belgium, Belize, Bermuda Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, The former Yugoslav, Malaysia, Mexico, Moldova, Republic of, Montenegro, Morocco, Netherlands, Nicaragua, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukrainian SSR, United Arab Emirates (UAE) United Kingdom, Uruguay, Venezuela and Yugoslavia.
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Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients. Class II

Reason: Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.

Nellcor Puritan Bennett Inc. (dba Covidien LP) 20130125 Terminated
Distributed: Worldwide Distribution: US (nationwide) and Internationally to: Albania, Argentina, Australia, Bahrain, Belgium, Belize, Bermuda Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, The former Yugoslav, Malaysia, Mexico, Moldova, Republic of, Montenegro, Morocco, Netherlands, Nicaragua, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukrainian SSR, United Arab Emirates (UAE) United Kingdom, Uruguay, Venezuela and Yugoslavia.
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Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair. Class II

Reason: Product labeling does not match product configuration.

Davol, Inc., Subs. C. R. Bard, Inc. 20140103 Terminated
Distributed: Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
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Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair. Class II

Reason: Product labeling does not match product configuration.

Davol, Inc., Subs. C. R. Bard, Inc. 20140103 Terminated
Distributed: Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
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