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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 April 21, 2022
Create Date June 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1297-2022
Recall Event ID 90295
Product Classification Catheter, cholangiography - Product Code GBZ
Product Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Product REF Number: 15028
Code Information UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010 
Recalling Firm/
Manufacturer
Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information Contact SAME
603-880-1433
Manufacturer Reason
for Recall
Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date
FDA Determined
Cause 2
Under Investigation by firm
Action Getinge issued Urgent Medical Device Removal to consignees via FedEx with Signature Proof of Delivery on 4/21/22. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the Atrium Firm PVC Thoracic Catheter 28French with the REF/LOT number listed in this notice. Should you have any affected product, please remove from area(s) of use. The LOT Number (ME231010) can be found on the product label illustrated. " If you have affected product, you are entitled to a replacement at no cost to your facility. You will receive a replacement upon your acknowledgement that you have affected product for return. " Please forward this information to all current and potential thoracic cathether users within your hospital / facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Please contact your local Atrium/Getinge Customer Service department to request a return authorization (RMA) and shipping instructions to return any affected product. Whether or not you have affected product(s) with the REF/LOT numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE- REMOVAL RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to thoracicCatheter2022.Atrium@getinge.com or by faxing the form to (877) 435-7043. 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 Commerce 56 cases (560 units / 10 units per case)
Distribution AZ IL KS LA MI NY OH OK TX VA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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