Recalls / —
—#135862
Product
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
- FDA product code
- PAD — Chest Drainage Kit
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K043140, K043582, K081718
- Affected lot / code info
- Lot Numbers: 222115, 222118, 222528
Why it was recalled
Chest drains have a missing o-ring
Root cause (FDA determination)
Process control
Action the firm took
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).
Recalling firm
- Firm
- Atrium Medical Corporation
- Address
- 5 Wentworth Dr, Hudson, New Hampshire 03051-4929
Distribution
- Distribution pattern
- Nationwide Canada, Germany
Timeline
- Recall initiated
- 2015-05-07
- Posted by FDA
- 2015-06-29
- Terminated
- 2016-04-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #135862. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.