CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Ocean Blood Recovery Drains as follows recalled by Atrium Medical
Atrium Medical is recalling Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line, distributed nationwide in the US. The recall was initiated on 29 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1082-2017
- FDA event ID
- 75599
- Recalling firm
- Atrium Medical, Hudson, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Nov 2016
- FDA classified
- 24 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 29 Nov 2016 | Recall initiated by company | |
| 24 Jan 2017 | Classified by FDA | +56 days |
| 1 Feb 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Outer Packaging is not sterile
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 stopcock - 2 patient lines connected by one Y connector 2052-300 Ocean Double Blood Recovery drain with suction control stopcock, no in-line connector - 2 patient lines connected by one Y connector 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 mediastinal area.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,
Questions about this recall
Why was it recalled?
Outer Packaging is not sterile
Which lots are affected?
All Lot Numbers With Expiration Date Prior To October 2019
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 75599This product is part of a recall event; the main page for the event is 400 Series Express Drains as follows recalled by Atrium Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 400 Series Express Drains as follows recalled by Atrium Medical | Atrium Medical | Sterility | Nationwide | |
| CLASS II | Dual Chamber Ocean Drains as follows recalled by Atrium Medical | Atrium Medical | Sterility | Nationwide | |
| CLASS II | Oasis Pediatric Drain as follows recalled by Atrium Medical | Atrium Medical | Sterility | Nationwide | |
| CLASS II | Oasis Single Drain as follows recalled by Atrium Medical | Atrium Medical | Sterility | Nationwide | |
| CLASS II | Pediatric Chamber Ocean Drains as follows recalled by Atrium Medical | Atrium Medical | Sterility | Nationwide | |
| CLASS II | Ocean Drains as follows: 2002-000 Ocean single drain recalled | Atrium Medical | Sterility | Nationwide | |
| CLASS II | 16400 Express Mini 500 dry seal drain recalled by Atrium Medical | Atrium Medical | Sterility | Nationwide | |
| CLASS II | 3620-100: Oasis dual chamber drain with in-line connectors recalled | Atrium Medical | Sterility | Nationwide | |
| CLASS II | Oasis Blood Recovery Drains as follows recalled by Atrium Medical | Atrium Medical | Sterility | Nationwide |
More recalls from Atrium Medical
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | iCast Covered Stent, 6MMx16MMx120CM recalled by Atrium Medical | Atrium Medical | Other | Nationwide |
| Device | CLASS II | Advanta Vxt, 1gds, Nh, Str-sw recalled by Atrium Medical | Atrium Medical | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |