PVC Thoracic Catheters recallZ-1297-2022 · Atrium Medical Corporation · initiated Apr 21, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Atrium Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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 [email protected] 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).
Recall details
- Recall number
- Z-1297-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 21, 2022
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 56 cases (560 units / 10 units per case)
- Product code
- GBZ
- Distribution
- AZ IL KS LA MI NY OH OK TX VA
Product description
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 (models, lots, serial numbers)
UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PVC Thoracic Catheters 15028Atrium Medical Corporation · Catheter, Cholangiography1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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