MEDLINE INDUSTRIES, LP – Northfield Recall 95628
Description: Lab Kit, SKU DYLAB1018; Component No. 503581
MEDLINE INDUSTRIES, LP – Northfield Recall 95628 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0355-2025 |
Event ID | 95628 |
Event Description | Lab Kit, SKU DYLAB1018; Component No. 503581 |
Product Type | Devices |
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) |
Recall 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. |
Device Classification | 20241120 |
Device Code Info | UDI-DI: 40195327088393 (Case); 10195327088392 (Ea) Lots: 24IMC246 |
Center Classification Date | 20241112 |
Recall Initiation Date | 20241023 |
Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
Initial Notification | Letter |
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