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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium Medical

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  Class 2 Device Recall Atrium Medical see related information
Date Initiated by Firm May 07, 2015
Date Posted June 29, 2015
Recall Status1 Terminated 3 on April 26, 2016
Recall Number Z-1937-2015
Recall Event ID 71023
510(K)Number K081718  K043582  K043140  
Product Classification Chest drainage kit - Product Code PAD
Product Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC
P/N: 3600-100
Code Information Lot Numbers: 222115, 222118, 222528 
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
5 Wentworth Dr
Hudson NH 03051-4929
For Additional Information Contact Same
603-880-1433
Manufacturer Reason
for Recall		 Chest drains have a missing o-ring
FDA Determined
Cause 2		 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 in Commerce 1170 cases
Distribution Nationwide Canada, Germany
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PAD and Original Applicant = ATRIUM MEDICAL CORP.
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