Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Atrium Ocean Wet Suction Water Seal Chest Drain

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Atrium Ocean Wet Suction Water Seal Chest Drainsee related information
Date Initiated by FirmOctober 18, 2022
Date PostedNovember 15, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0235-2023
Recall Event ID 91043
510(K)NumberK043582 
Product Classification Bottle, collection, vacuum - Product Code KDQ
ProductAtrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Code Information UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226
FEI Number 3011175548
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information ContactSAME
603-880-1433
Manufacturer Reason
for Recall		Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
FDA Determined
Cause 2		Storage
ActionAtrium/ Getinge issued Urgent Medical Device Removal on 10/18/21 via email with Delivery and Read receipt. Letter states reason for recall, health risk and action to take: Our records indicate that McKesson has received the Atrium Ocean Wet Suction Water Seal Chest Drains from the lot listed on Page 1. " Please examine your inventory and confirm that you have no remaining Atrium Ocean Wet Suction Water Seal Chest Drain 2002-000 with the REF/LOT number listed in this notice. Please return any product that may be affected under this Field Action. " Please respond to this email using the response form on page 3 to acknowledge that you have received this notification. If you have any questions, please contact your Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in Commerce24 units (4cases/6)
DistributionUS Nationwide distribution in the state of VA.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KDQ
-
-