—#194072

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

FDA product code: GBZ — Catheter, Cholangiography
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Atrium Medical Corporation
Address: 40 Continental Blvd, Merrimack, New Hampshire 03054-4332

Distribution

Distribution pattern: AZ IL KS LA MI NY OH OK TX VA

Timeline

Recall initiated: 2022-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194072. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.