Z-1297-2022 Class II Ongoing
FDA device recall Z-1297-2022 was initiated by Atrium Medical Corporation on Apr 21, 2022 and is designated Class II. 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 recall status is ongoing. Affected quantity: 56 cases (560 units / 10 units per case).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 6, 2022
- Initiation Date
- Apr 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 cases (560 units / 10 units per case)
Product Description
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
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 Pattern
AZ IL KS LA MI NY OH OK TX VA
Code Information
UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1297-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026