Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
FDA Recall Z-1935-2015 · Posted 2015-06-29
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Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodePAD
Date Initiated2015-05-07
Date Terminated2016-04-26
Product Quantity390 cases
Reason for Recall
Chest drains have a missing o-ring
Firm 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).
Root Cause
Process control
Distribution Pattern
Nationwide Canada, Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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