FDA Enforcement
Class II
Ongoing
Lab Kit, SKU DYLAB1018; Component No. 503581
Recall: Z-0355-2025
·
Reported November 20, 2024
Enforcement
- Recall Number
- Z-0355-2025
- Event ID
- 95628
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 20, 2024
- Initiation Date
- October 23, 2024
- Classification Date
- November 12, 2024
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
Lab Kit, SKU DYLAB1018; Component No. 503581
Reason
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Code Info
UDI-DI: 40195327088393 (Case); 10195327088392 (Ea) Lots: 24IMC246
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Quantity
626,305 Total Kits (US only)