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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1081-2017 - Atrium Medical Pediatric Chamber Ocean Drains as follows:
2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ® in. Tubing, Sims and Pedi connector in bag on ...
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2
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01/24/2017
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Atrium Medical Corporation
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Z-1079-2017 - Atrium Medical Ocean Drains as follows:
2002-000 Ocean single drain, with in-line connectors and suction control stopcock
2002-040 Ocean single drain, in-line connector and suction control stopcoc...
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2
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01/24/2017
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Atrium Medical Corporation
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Z-1082-2017 - Atrium Medical Ocean Blood Recovery Drains as follows:
2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock
2050-300 Ocean Blood Recovery drain with suction cont...
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2
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01/24/2017
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Atrium Medical Corporation
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Z-1083-2017 - Atrium Medical Oasis Single Drain as follows:
3600-100 Oasis single drain with in-line connector
3600-150 Oasis single drain with in-line connector and Pre-connected 2550 ATS Bag
Product Usage:...
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2
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01/24/2017
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Atrium Medical Corporation
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Z-1084-2017 - Atrium Medical Oasis Pediatric Drain as follows:
3612-100 Oasis Infant/Pediatric drain with in-line connector, ® in. tubing, Sims and Pedi connector in bag on back of drain
3612-400 Oasis Infant/Pe...
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2
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01/24/2017
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Atrium Medical Corporation
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Z-1086-2017 - Atrium Medical Oasis Blood Recovery Drains as follows:
3650-100 Oasis Blood Recovery drain with in-line connector
3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient line...
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2
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01/24/2017
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Atrium Medical Corporation
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Z-1080-2017 - Atrium Medical Dual Chamber Ocean Drains as follows:
2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes)
2020-100 Ocean dual chamber with in-line connecto...
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2
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01/24/2017
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Atrium Medical Corporation
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Z-1085-2017 - Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes)
Product Usage:
To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish l...
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2
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01/24/2017
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Atrium Medical Corporation
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Z-1088-2017 - Atrium Medical 16400 Express Mini 500 dry seal drain
Product Usage:
To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dyn...
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2
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01/24/2017
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Atrium Medical Corporation
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Z-1087-2017 - Atrium Medical 400 Series Express Drains as follows:
4000-100N Express single collection drain with in-line connector
4000-100P Express PreFilled Chest Drain
4020-100N Express dual chamber drain ...
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2
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01/24/2017
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Atrium Medical Corporation
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