Z-1297-2022Class II

Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the...

Name: Z-1297-2022 Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the...
Creator: Atrium Medical Corporation
Published: 2022-04-21
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2022-04-21 / Open, Classified / root cause: labeling and UDI

FDA source

Atrium Medical Corporation began a recall of 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... on 2022-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1297-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-21
Posted: 2022-06-28
Recalling firm: Atrium Medical Corporation
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
Product code: GBZ Catheter, Cholangiography
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
Root cause tag: labeling and UDI
FDA root cause: 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 [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).
Quantity in commerce: 56 cases (560 units / 10 units per case)
Distribution: AZ IL KS LA MI NY OH OK TX VA
Product codes and lots: UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1297-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1297-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-28

Product code GBZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)