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
Check against the official notice below — it lists the full affected range.
Atrium Medical Corporation is recalling Atrium Firm PVC Thoracic Catheters (28 French, product reference 15028) used to remove air and fluid from the chest cavity or mediastinum. The recall affects 56 cases containing 560 units distributed in Arizona, Illinois, Kansas, Louisiana, Michigan, New York, Ohio, Oklahoma, Texas, and Virginia. The problem involves a mismatch between expiration dates: the sterile barrier pouch label showed an expiration date of September 16, 2024, while the case and shipper labels showed September 21, 2024, potentially resulting in the product being used up to five days past its true expiration date.
The recall was issued because the conflicting expiration dates created the risk that the product would be used after it had actually expired, which could compromise the sterile barrier and safety of the catheter. The affected lot number is ME231010. The source record does not specify a remedy or course of action for consumers who may have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: AZ IL KS LA MI NY OH OK TX VA Quantity: 56 cases (560 units / 10 units per case) Lot/code info: UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.