FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
- Recall number
- Z-1937-2015
- Recalling firm
- Atrium Medical Corporation
- Product
- Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
- Status
- Terminated
- Initiated
- 2015-05-07
- Posted
- 2015-06-29
- Terminated
- 2016-04-26
- Reason
- Chest drains have a missing o-ring
- 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: connector@atriummed.com 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
- 1170 cases
- Distribution
- Nationwide Canada, Germany
- Lot, serial or model codes
- Lot Numbers: 222115, 222118, 222528
- 510(k) numbers
- ["K043140","K043582","K081718"]
- PMA numbers
- not on file
- Product code
- PAD
- Firm FEI
- 3011175548
- Firm city
- Hudson
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28