Z-0484-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- September 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2460 units (246 cases, 10 units/case)
Product Description
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Reason for Recall
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Distribution Pattern
US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
Code Information
UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.