🍔 Food 💊 Drugs 🏥 Medical Devices
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. Class II

Reason: Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

Siemens Healthcare Diagnostics, Inc. 20130422 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
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HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. Class II

Reason: Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

Siemens Healthcare Diagnostics, Inc. 20130422 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
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PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. Class II

Reason: Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.

SpineFrontier, Inc. 20130911 Terminated
Distributed: US Distribution: including states of: TX and VA.
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Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone. Class II

Reason: Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.

Aesculap, Inc. 20131209 Terminated
Distributed: Worldwide Distribution - USA including TX, NY, PA, and TN. Internationally to Austria, Switzerland, Germany, Denmark, Spain, Finland, France, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, and Taiwan.
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Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum. Class II

Reason: Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open.

Integra LifeSciences Corp. 20131113 Terminated
Distributed: Worldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX. Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.
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Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum. Class II

Reason: Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type package were found prior to use but after the sterile package was open

Integra LifeSciences Corp. 20131113 Terminated
Distributed: Worldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX. Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.
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Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients. Class I

Reason: Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.

Covidien 20131216 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to Austria, Estonia, Belgium, Spain, Italy, Poland, Bulgaria, Finland, Portugal, Switzerland, France, Lithuania, Romania, Cyprus, Great Britain, Czech Republic, Greece, Latvia, Slovenia, Germany, Hungary, Slovak Republic, Ireland, Netherlands, Turkey, Croatia, Andorra, Albania, Algeria, Bahrain, Bosnia and Herzegovina, Egypt, Georgia, Iran, Iraq, Israel, Jordan, Kenya, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Morocco, Russia, Saudi Arabia, Serbia, South Africa, Syria, Sudan, Tunisia, UAE, Uganda, Puerto Rico, Mexico, Columbia, Chile, Brazil, Argentina, Uruguay, Panama, Costa Rica, Peru, China, Korea, Japan, Taiwan, Hong Kong, Malaysia, Singapore, Sri Lanka, Australia, New Zealand.
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Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number Class II

Reason: TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs due to potential safety issue related to the use of this product producing uncommanded X-ray.

Trans American Medical, Inc. 20130822 Terminated
Distributed: US Distribution: including states of: WA and UT.
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EOS System X- ray beam Digital radiography system used in general radiographic examinations. Class II

Reason: EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.

EOS Imaging 20131107 Terminated
Distributed: Nationwide Distribution
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Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. Class II

Reason: It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.

Carestream Health Inc. 20130829 Terminated
Distributed: Nationwide
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