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Showing 65801–65820 of 68218 results

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Baxter Healthcare Corp. Rt.: Baxter Interlink System Non-DEHP Y-Type Catheter Extensio...

The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

FDAAug 3, 2005Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Mini-Infuser Microbore Extension Set, product code...

The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

FDAAug 3, 2005Nationwide• Baxter Healthcare Corp. Rt.

Plus Orthopedics USA: TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436

Did not meet specifications.

FDAAug 3, 2005AZ, CA, ID +3 more• Plus Orthopedics USA

Plus Orthopedics USA: TC-PLUS Tibial Insert 2; 15mm, Model 25309

Did not meet specifications.

FDAAug 3, 2005AZ, CA, ID +3 more• Plus Orthopedics USA

Baxter Healthcare Corp. Rt.: Baxter Extension Set, product code 2C9219; An Rx sterile,...

The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

FDAAug 3, 2005Nationwide• Baxter Healthcare Corp. Rt.

Plus Orthopedics USA: TC-PLUS Tibial Insert UC 4; 13mm, Model 25428

Did not meet specifications.

FDAAug 3, 2005AZ, CA, ID +3 more• Plus Orthopedics USA

Plus Orthopedics USA: TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Mod...

Did not meet specifications.

FDAAug 3, 2005AZ, CA, ID +3 more• Plus Orthopedics USA

Plus Orthopedics USA: TC-PLUS Tibial Insert UC 6; 13mm, Model 25438

Did not meet specifications.

FDAAug 3, 2005AZ, CA, ID +3 more• Plus Orthopedics USA

Plus Orthopedics USA: TC-PLUS Tibial Insert UC 4; 11mm, Model 25427

Did not meet specifications.

FDAAug 3, 2005AZ, CA, ID +3 more• Plus Orthopedics USA

Plus Orthopedics USA: TC-PLUS Tibial Insert UC 10; 11mm, Model 25457

Did not meet specifications.

FDAAug 3, 2005AZ, CA, ID +3 more• Plus Orthopedics USA

Baxter Healthcare Corp. Rt.: Baxter Interlink System Huber Needle Extension Set, produ...

The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

FDAAug 3, 2005Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Minivolume Extension Set, 72'', product code 2C568...

The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

FDAAug 3, 2005Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 60...

The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

FDAAug 3, 2005Nationwide• Baxter Healthcare Corp. Rt.

Siemens Medical Solutions USA, Inc: Siremobil Compact L Mobile X-Ray System

Screws may become loose and fall into the OR field during surgery.

FDAAug 1, 2005Nationwide• Siemens Medical Solutions USA, Inc

Inogen, Inc: Portable Oxygen Generator

Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.

FDAAug 1, 2005Nationwide• Inogen, Inc

Alcon Laboratories, Inc.: LADARVision Excimer Laser System.

Alcon has identified a software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on CustomCornea procedures, possibly adversely affecting clinical outcomes.

FDAAug 1, 2005IN• Alcon Laboratories, Inc.

Siemens Medical Solutions USA, Inc: Arcadis Varic Mobile X-Ray System

Screws may become loose and fall into the OR field during surgery.

FDAAug 1, 2005Nationwide• Siemens Medical Solutions USA, Inc

Cook Urological, Inc.: Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, ...

Mislabeled as to size.

FDAAug 1, 2005CA, FL• Cook Urological, Inc.

Siemens Medical Solutions USA, Inc: Arcadis Orbic Mobile X-Ray System

Screws may become loose and fall into the OR field during surgery.

FDAAug 1, 2005Nationwide• Siemens Medical Solutions USA, Inc

Linvatec Imaging: Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Num...

Through the complaint handling system, the company has determine there are performance issued involving the LS7500, 300 Watt Xenon Light Source. The performance issues result in a low light output that can create poor illumination of the surgical site.

FDAAug 1, 2005Nationwide• Linvatec Imaging

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