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Devices
Device Recall PleuraGuide Kit
Model / Serial
Part Number: 17100: 10734588, 10734583, 10728237, 10728236, 10728235, 10728234, 10736244, 10736243, 10736242, 10736238, 10734590, 10734589, 10736245, 10852352, 10847222, 10847218, 10842301, 10842299, 10842297, 10840114, 10834292, 10829188, 10852337, 10852334, 10834291, 10834286, 10834284, 10860795, 10857119, 10857111, 10864592, 10864104, 10856867, 10875059, 10875046 , 10871063, 10871059, 10868989, 10879191, 10879190, 10889037, 10887634, 10887292, 10884093, 10879192, 10891329, 10884084;Part Number: 17150: 10728238, 10734584, 10823084, 10800926, 10827874, 10827874, 10834299, 10857110, 10881097, 10874228, 10867130; Part Number 17200: 10728239, 10734585, 10794372, 10802727, 10802725, 10820803, 10825183, 10834338, 10852339, 10864105, 10884087
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. || Indicated to assist with the insertion of thoracic catheters.
Manufacturer
Atrium Medical Corporation
1 Event
Recall of Device Recall PleuraGuide Kit
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Manufacturer
Atrium Medical Corporation
Manufacturer Address
Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
Manufacturer Parent Company (2017)
Getinge AB
Source
USFDA
Language
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