Z-0359-2025 Class II Ongoing
FDA device recall Z-0359-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Oct 23, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 626,305 Total Kits (US only).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2024
- Initiation Date
- Oct 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 626,305 Total Kits (US only)
Product Description
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Code Information
UDI/DI: 40195327139941 (Case), 10195327139940 (Ea), Lots 22HLA350 22HLB291