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Showing 62201–62220 of 68218 results

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Hach Co: HACH SteriChek Sensitive Total Chloramines and Residual C...

Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results

FDAMay 23, 2008Nationwide• Hach Co

Biomet, Inc.: Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna wit...

The component in the package is not the correct size.

FDAMay 23, 2008CA, IL, IN +3 more• Biomet, Inc.

Terumo Cardiovascular Systems Corporation: Terumo Sarns Level Sensor II (yellow) (Part # 195215) ale...

The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.

FDAMay 23, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation: Terumo Sarns Level Sensor II (red) (Part # 195274) alarm ...

The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.

FDAMay 23, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Abbott Laboratories, Inc: ARCHITECT c8000 Processing Module, for in vitro diagnosti...

Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.

FDAMay 23, 2008PR• Abbott Laboratories, Inc

Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila: AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 o...

AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file. The instrument might require installation of the AxSYM Digoxin II assay file.

FDAMay 22, 2008AL, AZ, AR +25 more• Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila

Biomet Microfixation, Inc.: Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ...

The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997.

FDAMay 21, 2008Nationwide• Biomet Microfixation, Inc.

Siemens Medical Solutions Diagnostics: COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device i...

The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other methods, including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for example, approximately 20% lower when compared to results obtained with the IMMULITE 2000 Third Generation PSA assay (L2KUP).

FDAMay 21, 2008Nationwide• Siemens Medical Solutions Diagnostics

Medtronic Neuromodulation: Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimula...

Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling issue. The package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm. Recalled lots are to be returned for replacement or credit.

FDAMay 21, 2008AL, AZ, AR +41 more• Medtronic Neuromodulation

Varian Medical Systems Oncology Systems: Varis Aria Radiation Oncology Version 8.1, manufactured b...

Dose delivery may be altered after import from a third party planning system during radiation therapy.

FDAMay 21, 2008Nationwide• Varian Medical Systems Oncology Systems

Medacta Usa Inc: Medacta AMIS Universal Table for Leg Positioner, Model N...

Medacta is issuing this Recall because improper connection of the table clamping mechanism may result in the AMIS table becoming separated from the surgical table resulting in injury to the patient.

FDAMay 21, 2008Nationwide• Medacta Usa Inc

Hansen Medical Inc: Artisan Control Catheter, model number 04454, manufacture...

The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism.

FDAMay 21, 2008Nationwide• Hansen Medical Inc

Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa: SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, ...

The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

FDAMay 20, 2008Nationwide• Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa

Wright Medical Technology Inc: Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx o...

Trials are 2.5mm larger than marked.

FDAMay 20, 2008Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only,...

Trials are 2.5mm larger than marked.

FDAMay 20, 2008Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx o...

Trials are 2.5mm larger than marked.

FDAMay 20, 2008Nationwide• Wright Medical Technology Inc

Boston Scientific Corporation: Boston Scientific FilterWire EZ" Embolic Protection Syste...

Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be missing. If the product does not include a DFU and the user is unable to find a copy, the user will have to seek another product box containing the DFU. This may

FDAMay 20, 2008AL, AK, AZ +48 more• Boston Scientific Corporation

Datex Ohmeda, Inc. dba GE Healthcare: Panda iRes and Giraffe Infant Warmers, labeled in part***...

Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.

FDAMay 20, 2008Nationwide• Datex Ohmeda, Inc. dba GE Healthcare

Wright Medical Technology Inc: Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx o...

Trials are 2.5mm larger than marked.

FDAMay 20, 2008Nationwide• Wright Medical Technology Inc

The Anspach Effort, Inc.: "REF BLU-55 mm Fluted Ball. Use with B-BLUE-S Attac...

Laceration Risk

The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.

FDAMay 19, 2008Nationwide• The Anspach Effort, Inc.

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