# FDA recall Z-1297-2022

> **Atrium Medical Corporation** · Class II · device recall initiated 2022-04-21.

## 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

## 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

## Key facts

- **Recall number:** Z-1297-2022
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-21
- **Report date:** 2022-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Merrimack, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1297-2022

## Citation

> AI Analytics. FDA recall Z-1297-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1297-2022. Source: US FDA. Licensed CC0.

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