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Showing 64561–64580 of 68218 results

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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

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 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 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

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

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.

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.

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.

Smiths Medical ASD, Inc.: Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D....

The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.

FDAAug 11, 2006Nationwide• Smiths Medical ASD, Inc.

Medi Manufacturing Inc: Medipro OP4 Prosthetic Knee Joint (external for prosthesi...

Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.

FDAAug 11, 2006Nationwide• Medi Manufacturing Inc

Abbott Laboratories MPG: IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack c...

The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens.

FDAAug 11, 2006PR• Abbott Laboratories MPG

Cordis Neurovascular, Inc.: Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.

Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.

FDAAug 11, 2006Nationwide• Cordis Neurovascular, 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.

Becton Dickinson & Company: BD Vacutainer Push Button Blood Collection Set with Pre-a...

A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity.

FDAAug 11, 2006Nationwide• Becton Dickinson & Company

Datex Ohmeda, Inc: GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery Syst...

Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alrm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected.

FDAAug 10, 2006AL, AK, CA +13 more• Datex Ohmeda, Inc

Cardinal Health 303 Inc DBA Alaris Products: Alaris SE Pump (formerly Signature Edition Infusion Pump)...

This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.

FDAAug 10, 2006Nationwide• Cardinal Health 303 Inc DBA Alaris Products

Data Innovations, Inc.: Data Innovations Instrument Manager Version 8:00, 8.01, 8...

Patient results may be associated with an incorrect specimen

FDAAug 10, 2006Nationwide• Data Innovations, Inc.

Bock, Otto, Orthopedic Ind, Inc Two Carlson: Electronic Otto Bock Compact leg prosthesis System, 3C95/...

A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer.

FDAAug 10, 2006Nationwide• Bock, Otto, Orthopedic Ind, Inc Two Carlson

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