FDA (Devices) recall action 75599

Atrium Medical Corporation recalled 10 products on 2017-02-01

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2017-02-01
Critical: 0
Units: —

Why these products were recalled

Outer Packaging is not sterile

The agency’s own wording, quoted from the enforcement report.

1–10 of 10

ModerateFDA (Devices)··2017-02-01
Atrium Medical Ocean Drains Recalled Due to Non-Sterile Outer Packaging
Atrium Medical is recalling Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Product
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 stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with
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Distribution
0 states
ModerateFDA (Devices)··2017-02-01
Atrium Medical Oasis Pediatric Drain Recalled for Non-Sterile Packaging
Atrium Medical is recalling Oasis Pediatric Drains because the outer packaging is not sterile. The recall covers 964,463 US cases and 521,975 international cases.
Product
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/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector i
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0 states
ModerateFDA (Devices)··2017-02-01
Atrium Medical Recalls Dual Chamber Ocean Drains Due to Sterility Issues
Atrium Medical is recalling Dual Chamber Ocean Drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.
Product
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 connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual chambe
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0 states
HighFDA (Devices)··2017-02-01
Atrium Medical Oasis Single Drain Recalled for Non-Sterile Packaging
Atrium Medical is recalling Oasis Single Drains because the outer packaging is not sterile, posing a risk of infection.
Product
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: To evacuate air and/or fluid from the chest cavity or mediastinum. To help r
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0 states
ModerateFDA (Devices)··2017-02-01
Atrium Medical Express Mini 500 Dry Seal Drain Recall
Atrium Medical is recalling Express Mini 500 dry seal drains because the outer packaging is not sterile.
Product
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 dynamics. To facilitate postoperative collection and reinfusion of autologous blo
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0 states
ModerateFDA (Devices)··2017-02-01
Atrium Medical 400 Series Express Drains Recalled for Non-Sterile Packaging
Atrium Medical is recalling 400 Series Express Drains because the outer packaging is not sterile. The recall affects approximately 1.4 million cases distributed worldwide.
Product
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 with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery dra
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0 states
HighFDA (Devices)··2017-02-01
Atrium Medical Recalls Pediatric Ocean Drains Due to Non-Sterile Packaging
Atrium Medical is recalling Pediatric Chamber Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Product
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 back of drain Product Usage: To evacuate air and/or fluid from the chest cav
Category
Distribution
0 states
HighFDA (Devices)··2017-02-01
Atrium Medical Oasis Dual Chamber Drain Recall Due to Sterility Issue
Atrium Medical is recalling Oasis dual chamber drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.
Product
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 lung expansion and restore breathing dynamics. To facilitate postoperative coll
Category
Distribution
0 states
ModerateFDA (Devices)··2017-02-01
Atrium Medical Recalls Oasis Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Oasis Blood Recovery Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Product
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 lines connected by one Y connector Product Usage: To evacuate air and/or fluid f
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Distribution
0 states
ModerateFDA (Devices)··2017-02-01
Atrium Medical Recalls Ocean Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Ocean Blood Recovery Drains because the outer packaging is not sterile. The recall affects units worldwide with expiration dates prior to October 2019.
Product
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 control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain w
Category
Distribution
0 states