Device product
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Z-0484-2024
Product summary
- Event
- Event 93408
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2460 units (246 cases, 10 units/case)
- Official record key
device-enforcement:Z-0484-2024
Official wording
Reason: A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Code information: UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.
Distribution pattern: US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
Derived failure modes
-
Unknown
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.