Device 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
Z-1297-2022
Product summary
- Event
- Event 90295
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 56 cases (560 units / 10 units per case)
- Official record key
device-enforcement:Z-1297-2022
Official wording
Reason: 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
Code information: UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010
Distribution pattern: AZ IL KS LA MI NY OH OK TX VA
Derived failure modes
-
Unknown
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