Device recall: Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control…

Class II FDA enforcement event 75599. Recall start date: 29 Nov 2016. Status in the FDA record: Terminated. Termination date: 29 Sep 2020.

Reason for recall, in the words of FDA

Outer Packaging is not sterile

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Atrium Medical Corporation started this device recall on 29 Nov 2016. The firm address in the FDA record is in Hudson, NH. FDA put the recall in Class II. FDA event 75599 has 10 product records. The first FDA enforcement report date is 1 Feb 2017. The record gives the status Terminated, with the termination date 29 Sep 2020.

FDA enforcement report The 10 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great…

Recalling firm

Atrium Medical Corporation, Hudson, NH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

10 product records in the event.

FDA event 75599: product records
Recall number	Product	Quantity	Class	Status	Report date
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 stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with in-line connector and suction control…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017
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 connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual chamber with suction control stopcock, no…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017
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 back of drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. “ To help re-establish…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017
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 control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain with in-line connector and suction control…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017
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: To evacuate air and/or fluid from the chest cavity or mediastinum. “ To help re-establish lung expansion and restore…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017
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/Pediatric drain with no in-line connector, in. tubing, Sims and Pedi connector in bag on back of drain Product Usage: To…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017
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 lung expansion and restore breathing dynamics. “ To facilitate postoperative collection and reinfusion of autologous…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017
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 lines connected by one “Y” connector Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. “ To…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017
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 with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery drain with in-line connector 4050-100P Express…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017
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 dynamics. “ To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or…	964,463 cases (US) 521,975 cases (OUS) in total	Class II	Terminated	1 Feb 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 10Median of the firm: 1
Events of the firm on the register: 29

Other events of the firm

Other FDA enforcement events of Atrium Medical Corporation
Initiated	Product (first record)	Type	Class	Records
7 Aug 2026	Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR	Device	Class II	3
9 Sep 2024	iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616	Device	Class II	1
3 May 2024	ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft	Device	Class II	68
1 Nov 2023	Atrium Oasis Drain Single W / AC, Part No. 3600-100	Device	Class II	1
29 Sep 2023	Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.	Device	Class II	1
21 Sep 2023	Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of t	Device	Class II	1
18 Sep 2023	Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-	Device	Class II	3
5 Sep 2023	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION	Device	Class II	2
1 Mar 2023	Atrium Pneumostat Chest Drain Valve, Part Number 16100	Device	Class II	2
18 Oct 2022	Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000	Device	Class II	1

Atrium Medical Corporation: all 29 events

Official channels

FDA enforcement report Z-1079-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 75599. https://recallregister.com/fda/ii/75599/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great…
What quantity of product is in FDA event 75599?: The event has 10 product records. The first record gives this quantity: 964,463 cases (US) 521,975 cases (OUS) in total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.