Z-1935-2015Class II

Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000

Name: Z-1935-2015 Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Creator: Atrium Medical Corporation
Published: 2015-05-07
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2015-05-07 / Terminated / root cause: manufacturing process

FDA source

Atrium Medical Corporation began a recall of Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000 on 2015-05-07. FDA classified it as Class II and gives the reason as "Chest drains have a missing o-ring". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1935-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-07
Posted: 2015-06-29
Terminated: 2016-04-26
Recalling firm: Atrium Medical Corporation
Product: Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Product code: PAD Chest Drainage Kit
Reason for recall: Chest drains have a missing o-ring
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Atrium Medical issued recall letter dated 5/7/15 to inform customers of the steps to take should they encounter affected product. If the O-ring is not present on the patient tubing: a. Do not use the chest drain. b. Replace the entire chest drain including the patient tubing. Open up another chest drain package and repeat steps 1 to 3. c. Return any units with missing O-rings to Atrium. If the O-ring is present then reconnect in-line connector and proceed with set up as normal. Complete and return Field Action Reply Form to the following e-mail address: [email protected] or you may fax it to 1-603-386-6590. If you have any questions, please contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
Quantity in commerce: 390 cases
Distribution: Nationwide Canada, Germany
Product codes and lots: Lot Number: 222511

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1935-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1935-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-29
Z-1936-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-29
Z-1937-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-29
Z-1938-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-29

Product code PAD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)