Atrium Medical Corporation 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Atrium Medical Corporation
Lot Codes / Batch Numbers
UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010
Products Sold
UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010
Atrium Medical Corporation is recalling Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid due to Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch lab. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, IL, KS, LA, MI, NY, OH, OK, TX, VA
Page updated: Jan 10, 2026