Food, drugs, devices › Atrium Medical Corporation

Device recall: Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION

FDA enforcement event 93343 · Class II · initiated 5 Sep 2023 · status Ongoing

DeviceVoluntary: Firm initiated2 product recordsMerrimack, NH

FDA enforcement event 93343 is a device recall by Atrium Medical Corporation of Merrimack, NH, initiated 5 Sep 2023 and classified Class II, with 2 product records.

FDA defines Class II as 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. 88% of the 917 device enforcement events initiated in 2023 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Atrium Medical Corporation has 29 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Atrium Medical Corporation, Merrimack, NH.

Reason for recall

"Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation."

Distribution

"US: VA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0485-2024	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.	—	Class II	Ongoing	13 Dec 2023
Z-0486-2024	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY	—	Class II	Ongoing	13 Dec 2023

Context

88%of 2023 device events are Class II917 events that year

2product records in this eventfirm median: 1

29events on this register for the firm

Other enforcement events for 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
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
21 Apr 2022	Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavi	Device	Class II	1

All 29 events for Atrium Medical Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "US: VA"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.