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FDA Recalls

Showing 36,541–36,550 of 40,300 recalls

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STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments. Class II

Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

Advanced Sterilization Products 20131216 Terminated

Distributed: Nationwide Distribution

STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments. Class II

Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

Advanced Sterilization Products 20131216 Terminated

Distributed: Nationwide Distribution

STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments. Class II

Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

Advanced Sterilization Products 20131216 Terminated

Distributed: Nationwide Distribution

Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum. Class II

Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation 20131119 Terminated

Distributed: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum. Class II

Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation 20131119 Terminated

Distributed: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum. Class II

Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation 20131119 Terminated

Distributed: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum. Class II

Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation 20131119 Terminated

Distributed: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum. Class II

Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation 20131119 Terminated

Distributed: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum. Class II

Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation 20131119 Terminated

Distributed: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum. Class II

Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation 20131119 Terminated

Distributed: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

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