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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium

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  Class 2 Device Recall Atrium see related information
Date Initiated by Firm January 20, 2017
Create Date February 16, 2017
Recall Status1 Terminated 3 on November 03, 2020
Recall Number Z-1222-2017
Recall Event ID 76138
510(K)Number K831931  
Product Classification Catheter, cholangiography - Product Code GBZ
Product Atrium PVC 10 Fr Straight Thoracic Catheter
Code Number: 8010
Code Information All Lot Numbers With Expiration Date Prior To December 2019
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
5 Wentworth Dr
Hudson NH 03051-4929
For Additional Information Contact
603-880-1433
Manufacturer Reason
for Recall		 Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
FDA Determined
Cause 2		 Labeling design
Action Marquet/Atrium notified consignees by letter dated 01/20/17 informing of the Labeling Icon Clarification. The thoracic catheter labeling is being updated for future production. Users should be made aware of this Field Notification and may continue to use the affected thoracic catheter products with the current labeling. Questions, please contact your local Maquet/Atrium thoracic catheter representative or Maquet Customer Service at 1-800-528-7486 or 603-880-1433, Monday through Friday between 8:00 am and 5:00 pm (EST).
Quantity in Commerce 1394 cases (10/case)
Distribution Nationwide
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 = GBZ and Original Applicant = ATRIUM MEDICAL CORP.
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