RecallRadar

FDA Device recall Z-1205-2017

Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest ca…

On 2017-02-22 the FDA classified a Class II recall of Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest ca… by Atrium Medical, citing chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1205-2017
ClassificationClass II
Statusterminated
Initiated2016-12-23
Published2017-02-22
Last updated2026-09-13 11:54 UTC
CompanyAtrium Medical
DistributionUS

Product

Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: 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 patients pleural cavity or mediastinal area.

Reason

Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

Identifiers

code_infoLot Number: 242896, 243292

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-1205-2017%22

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