FDA Enforcement
Class II
Ongoing
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Recall: Z-0484-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0484-2024
- Event ID
- 93408
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Atrium Medical Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 13, 2023
- Initiation Date
- September 29, 2023
- Classification Date
- December 1, 2023
- Address
- 40 Continental Blvd, Merrimack, NH, 03054-4332, United States
Description
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Reason
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Code Info
UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.
Distribution
US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
Quantity
2460 units (246 cases, 10 units/case)