Date Initiated by Firm |
May 07, 2015 |
Date Posted |
June 29, 2015 |
Recall Status1 |
Terminated 3 on April 26, 2016 |
Recall Number |
Z-1936-2015 |
Recall Event ID |
71023 |
510(K)Number |
K081718 K043582 K043140
|
Product Classification |
Chest drainage kit - Product Code PAD
|
Product |
Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100 |
Code Information |
Lot Number: 222945 |
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 |
130 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.
|