Atrium Firm PVC Thoracic Catheter 28French-Intended to recall: Sterility Concern
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF…
Why was Atrium Firm PVC Thoracic Catheter 28French-Intended to 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010
- 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…
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 56 cases (560 units / 10 units per case)
- Distribution
- AZ IL KS LA MI NY OH OK TX VA
- Recall date
- July 6, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)