FDA Device recall 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 si…
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean si… by Atrium Medical, citing outer Packaging is not sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1079-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-29 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Atrium Medical |
| Distribution | US |
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 in-line connector and suction control stopcock, Pre-connected 2550 ATS Bag 2002-100 Ocean single drain with in-line connector, no suction control stopcock 2002-300 Ocean single drain with suction control stopcock, no in-line connector 2002-400 Ocean single drain, no in-line connector or suction control stopcock, Water ampoule 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.
Reason
Outer Packaging is not sterile
Identifiers
| code_info | All Lot Numbers With Expiration Date Prior To October 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1079-2017%22
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