Ocean Water Seal Chest Drain, Single Collection W/AC recallZ-1935-2015 · Atrium Medical Corporation · initiated May 7, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Atrium Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Chest drains have a missing o-ring
FDA root cause category: Process control
What the company is doing
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).
Recall details
- Recall number
- Z-1935-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 7, 2015
- Posted by the FDA
- Jun 29, 2015
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 390 cases
- Product code
- PAD
- FDA submissions
- K043140, K043582, K081718
- Distribution
- Nationwide Canada, Germany
Product description
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Code information (models, lots, serial numbers)
Lot Number: 222511
Other devices under the same FDA submission
12 devices cleared under K043140, K043582, K081718 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OCEAN 2002-300Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall10 reports
- OCEAN 2012-320Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 reports
- OASIS 3620-100Atrium Medical Corporation · Bottle, Collection, Vacuum51 reports
- OCEAN 2002-100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall0 reports
- OCEAN 2002-040Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall0 reports
- OCEAN 2020-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM32 reports
- OASIS 3612-400Atrium Medical Corporation · Bottle, Collection, Vacuum3 reports
- OCEAN 2020-100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 report
- OCEAN 2050-300Atrium Medical Corporation · Apparatus, Autotransfusion1 report
- OASIS 3600-150Atrium Medical Corporation · APPARATUS, AUTOTRANSFUSION1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 71023).
- Z-1936-2015 · TerminatedOcean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
- Z-1937-2015 · TerminatedOasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
- Z-1938-2015 · TerminatedEXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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