FDAApril 21, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Ongoing

Brands named

atrium medicalatrium

UPCs

2065086215028900650862150285

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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