Class 2 Device Recall Atrium 28Fr PVC Thoracic Catheter

• Date Initiated by Firm: October 12, 2018
• Create Date: December 06, 2018
• Recall Status: Terminated on May 12, 2020
• Recall Number: Z-0560-2019
• Recall Event ID: 81524
• 510(K)Number: K831931
• Product Classification: Catheter, cholangiography - Product Code GBZ
• Product: Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
• Code Information: ME221275
• FEI Number: 3011175548
• Recalling Firm/ Manufacturer: Atrium Medical Corporation; 40 Continental Blvd; Merrimack NH 03054-4332
• For Additional Information Contact: Ms. Maryanna Krivak; 973-709-7483
• Manufacturer Reason for Recall: This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved and the patient s risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.
• FDA Determined Cause: Vendor change control
• Action: The firm notified affected customers on October 29, 2018 via an Urgent Medical Device Recall letter. The letter alerted customers to the issue of the product's sterile barrier pouch not being properly sealed at the bottom. Customers were asked to do the following: 1. Examine your inventory to determine if you have the affected product listed in this Notification. If so, remove affected products, quarantine them, and place in a secure location. 2. If you have affected product, contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm (EST), for a Return Authorization (RA) to return the product for replacement or credit. 3. Complete and sign the enclosed Medical Device - Recall Response Form on Page 4 of this letter to acknowledge receipt of this notification. If you have affected product to return, enter the quantity and your RA number in the space provided. 4. Return the completed Medical Device - Recall Response Form to: EMAIL catheter2018.us@getinge.com or FAX 1-973-807-1654. If you have any questions, please contact your Getinge/Maquet representative or call Maquet Customer Service at 1-603-880-1433, Monday through Friday between the hours of 9:00 am to 5:00 pm Eastern Time Zone.
• Quantity in Commerce: 2930 units
• Distribution: Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.
• 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