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Showing 17481–17500 of 22534 results

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Abbott Point of Care Inc.: Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Ur...

Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

FDAOct 18, 2007Nationwide• Abbott Point of Care Inc.

Abbott Point of Care Inc.: Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hc...

Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

FDAOct 18, 2007Nationwide• Abbott Point of Care Inc.

Abbott Point of Care Inc.: Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); L...

Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

FDAOct 18, 2007Nationwide• Abbott Point of Care Inc.

Abbott Point of Care Inc.: Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Cre...

Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

FDAOct 18, 2007Nationwide• Abbott Point of Care Inc.

Abbott Point of Care Inc.: Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); ...

Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

FDAOct 18, 2007Nationwide• Abbott Point of Care Inc.

GE OEC Medical Systems, Inc: GE OEC, Insta Trak 3500 Plus with the Cranial Application...

Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.

FDAOct 18, 2007AL, AZ, AR +22 more• GE OEC Medical Systems, Inc

Siemens Medical Solutions Diagnostics: Clinitest hCG Cassette Pregnancy Test, Radio immunoassay ...

False positive hCG results

FDAOct 17, 2007Nationwide• Siemens Medical Solutions Diagnostics

Unknown Manufacturer: 3M ESPE Unitek Stainless Steel Permanent Molar Crowns , P...

Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns.

FDAOct 17, 2007CA, FL, IL +10 more

Beckman Coulter Inc: Access Power Supply Assembly Sled Part Number: A48196/684...

Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering.

FDAOct 17, 2007Nationwide• Beckman Coulter Inc

LifeCell Corporation: AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder...

Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody)

FDAOct 17, 2007NJ• LifeCell Corporation

Medtronic Navigation, Inc: Medtronic 0-arm Imaging System, Product Catalog Number: B...

Reversed Instrument Position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)

FDAOct 17, 2007CO, IN, MN +1 more• Medtronic Navigation, Inc

Respironics, Inc.: RP-Leaf, Check valve-5 pk model number F33440. Filter, ...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: Oximetry Ear Clip Sensor model number 948. Filter, mask...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Interpore Cross International Inc: Allogenix; DBM in a Lipid Carrier with Calcium Granules; ...

Unapproved Testing: Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human

FDAOct 15, 2007Nationwide• Interpore Cross International Inc

Respironics, Inc.: REMStar Heated Humidifier Pkg model number 1005792. Fil...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: Non-continuous ventilators accessories under the followin...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Sprint Fidelis 6948 Steroid eluting, quadripola...

Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of

FDAOct 15, 2007PR• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ...

Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of

FDAOct 15, 2007PR• Medtronic Inc. Cardiac Rhythm Managment

Respironics, Inc.: Omni Lab Core Domestic model number 1043343. Filter, ma...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: ECG Lead Set 60 in SOC to Snap model number 8049-1. Fil...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

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