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Showing 18921–18940 of 22584 results

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International Medsurg Connection, Inc.: Allegiance Esmark 6' x 144' Bandage, Latex Free, Sterile;...

The bandages labeled as sterile had not been sterilized prior to distribution.

FDAAug 16, 2006Nationwide• International Medsurg Connection, Inc.

International Medsurg Connection, Inc.: Allegiance Esmark 6' x 108' Bandage, Latex Free, Sterile;...

The bandages labeled as sterile had not been sterilized prior to distribution.

FDAAug 16, 2006Nationwide• International Medsurg Connection, Inc.

GE OEC Medical Systems, Inc: GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Sys...

X-ray systems could provide output which exceeds the 20 R/minute limit.

FDAAug 16, 2006Nationwide• GE OEC Medical Systems, Inc

Hitachi Medical Systems America Inc: MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, So...

Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.

FDAAug 16, 2006Nationwide• Hitachi Medical Systems America Inc

International Medsurg Connection, Inc.: Allegiance Esmark 4' x 144' Bandage, Latex Free, Sterile;...

The bandages labeled as sterile had not been sterilized prior to distribution.

FDAAug 16, 2006Nationwide• International Medsurg Connection, Inc.

Stryker Biotech: Calstrux (Previously known as TCP Putty)- Absorbable Bone...

Lack of Labeling Precautions. Calstrux should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or combination product usage, including localized induration, swelling, inflammation, wound drainage, infection and device migration.

FDAAug 16, 2006Nationwide• Stryker Biotech

International Medsurg Connection, Inc.: Allegiance Esmark 4' x 108' Bandage, Latex Free, Sterile;...

The bandages labeled as sterile had not been sterilized prior to distribution.

FDAAug 16, 2006Nationwide• International Medsurg Connection, Inc.

Unknown Manufacturer: Femoral Speed Block Size 2, Part/Catalog #800-01-365; pos...

Complaints received that device used to prepare femur to receive femoral implant would split during surgery.

FDAAug 15, 2006IN

Unknown Manufacturer: Femoral Speed Block Size 6, Part/Catalog #800-01-367; pos...

Complaints received that device used to prepare femur to receive femoral implant would split during surgery.

FDAAug 15, 2006IN

Unknown Manufacturer: Femoral Speed Block Size 10, Part/Catalog #800-01-369; po...

Complaints received that device used to prepare femur to receive femoral implant would split during surgery.

FDAAug 15, 2006IN

Unknown Manufacturer: Femoral Speed Block Size 12, Part/Catalog #800-01-370; po...

Complaints received that device used to prepare femur to receive femoral implant would split during surgery.

FDAAug 15, 2006IN

Unknown Manufacturer: Femoral Speed Block Size 8, Part/Catalog #800-01-368; pos...

Complaints received that device used to prepare femur to receive femoral implant would split during surgery.

FDAAug 15, 2006IN

Unknown Manufacturer: Femoral Speed Block Size 4 Part/Catalog #800-01-366; posi...

Complaints received that device used to prepare femur to receive femoral implant would split during surgery.

FDAAug 15, 2006IN

bioMerieux, Inc.: BacT/ALERT 3D Combo Systems Software, Blood Culturing System

Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

FDAAug 14, 2006Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: BacT/ALERT Classic System Software, Blood Culturing System

Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

FDAAug 14, 2006Nationwide• bioMerieux, Inc.

Hitachi Medical Systems America Inc: Hitachi Echelon Magnetic Resonance Imaging System, Serial...

Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.

FDAAug 14, 2006Nationwide• Hitachi Medical Systems America Inc

Kerr Corp: TempBond Clear Syringes (base and catalyst kit), a tempor...

Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)

FDAAug 14, 2006Nationwide• Kerr Corp

bioMerieux, Inc.: BacT/ALERT 3D 60 Systems Software, Blood Culturing System

Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

FDAAug 14, 2006Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: BacT/ALERT 3D System Software, Blood Culturing System

Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

FDAAug 14, 2006Nationwide• bioMerieux, Inc.

Respironics Novametrix, LLC.: NICO Model 7300 Cardiopulmonary Management System

Audible alarm may not sound during an alert condition

FDAAug 11, 2006PR• Respironics Novametrix, LLC.

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