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U.S. Department of Health and Human Services

Class 2 Device Recall PVC Trocar Thoracic Catheters

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  Class 2 Device Recall PVC Trocar Thoracic Catheters see related information
Date Initiated by Firm October 26, 2016
Create Date November 16, 2016
Recall Status1 Terminated 3 on October 09, 2018
Recall Number Z-0583-2017
Recall Event ID 75347
510(K)Number K831931  
Product Classification Catheter, cholangiography - Product Code GBZ
Product Atrium Medical 32 Fr Trocar catheter, Sterile
Model Number: 8432

Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Code Information All lot codes
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		 Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
FDA Determined
Cause 2		 Labeling design
Action Atrium Medical issued an "Urgent Medical Device Recall (Removal)" communication to customers on 10/26/16 via FedEx 2 day delivery. The recall identifies the problem, product, and risk factors. In addition, it provides instructions on how to handle product that may be affected. Accounts are to read the letter completely and share with all users and staff. They have been requested to complete the enclosed Recall Reply Form, acknowledging receipt of the notice; and, remove and quarantine any affected product for return. Additionally, obtain product from an alternate supplier because replacement product is not available as all Trocar catheters have been discontinued. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm, for a Return Goods Authorization to return the product and receive credit.
Quantity in Commerce 5055 cases (10/cs)
Distribution Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
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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