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Showing 63401–63420 of 68218 results

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Diasorin Inc.: 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. ...

25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.

FDAAug 21, 2007Nationwide• Diasorin Inc.

Inotech Biosystems Intl., Inc: Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10m...

Erroneous Coagulation Tests

FDAAug 20, 2007Nationwide• Inotech Biosystems Intl., Inc

Beckman Coulter Inc: Cytomics FC 500 Flow Cytometry System with Data Innovatio...

Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.

FDAAug 20, 2007Nationwide• Beckman Coulter Inc

Stryker Howmedica Osteonics Corp.: Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Rig...

A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.

FDAAug 20, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Karl Storz Endoscopy America Inc 600 Corporate Pointe: Storz Equipment, Fluid Management Stand, for Fluid Manage...

Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.

FDAAug 17, 2007Nationwide• Karl Storz Endoscopy America Inc 600 Corporate Pointe

Pml Microbiologicals Inc.: Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Mi...

Marketed a regulated product without a 510(k).

FDAAug 17, 2007PR• Pml Microbiologicals Inc.

Alphatec Spine, Inc.: Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733...

Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.

FDAAug 16, 2007Nationwide• Alphatec Spine, Inc.

Cook, Inc.: THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE co...

The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's name and address.

FDAAug 15, 2007Nationwide• Cook, Inc.

The Braun Corporation: Braun wheelchair lift, model NL, Braun Corporation, Wina...

The wheelchair lifts threshold warning system may not operate and the wheelchair user can fall from the vehicle and be seriously injured.

FDAAug 15, 2007Nationwide• The Braun Corporation

Baxter Healthcare Corp. Rt.: Baxter Colleague CX Single Channel Volumetric Infusion Pu...

Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.

FDAAug 15, 2007CA, FL• Baxter Healthcare Corp. Rt.

The Braun Corporation: Braun wheelchair lift, model NVL, Braun Corporation, Win...

The wheelchair lifts threshold warning system may not operate and the wheelchair user can fall from the vehicle and be seriously injured.

FDAAug 15, 2007Nationwide• The Braun Corporation

The Braun Corporation: Braun wheelchair lift, model NCL, Braun Corporation, Win...

The wheelchair lifts threshold warning system may not operate and the wheelchair user can fall from the vehicle and be seriously injured.

FDAAug 15, 2007Nationwide• The Braun Corporation

Merit Medical Systems, Inc: Merit Medical Surgical Convenience Kits, Custom and SPPT,...

Expiration Dating; Some Convenience Kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label.

FDAAug 15, 2007Nationwide• Merit Medical Systems, Inc

Smiths Medical MD, Inc.: Smiths Medical CADD-Sentry Pro Medication Safety Software...

Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator displayed the values correctly at data entry.

FDAAug 14, 2007CO, MD, UT• Smiths Medical MD, Inc.

Cardinal Health 303 Inc DBA Alaris Products: Pyxis Anesthesia System 3500, Cardinal Health, Clinical T...

System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.

FDAAug 13, 2007Nationwide• Cardinal Health 303 Inc DBA Alaris Products

GE Healthcare: GE Definium 8000 , model 5135678, Digital Radiographic Sy...

Necessary certification labels are missing from the x-ray contol.

FDAAug 13, 2007Nationwide• GE Healthcare

GE Healthcare: GE Precision 500D, model 2403790-3, Radiographic and Fluo...

Necessary certification labels are missing from the x-ray contol.

FDAAug 13, 2007Nationwide• GE Healthcare

C.R. Bard Access Systems, Inc: Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, ...

Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.

FDAAug 10, 2007Nationwide• C.R. Bard Access Systems, Inc

Summit Industries Inc.: PCS125 Swivel Collimator, Model F100; Manual Radiographic...

The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.

FDAAug 10, 2007Nationwide• Summit Industries Inc.

Summit Industries Inc.: LX125V Swivel Collimator, Model E600; Manual Radiographic...

The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.

FDAAug 10, 2007Nationwide• Summit Industries Inc.

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