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MEDLINE INDUSTRIES, LP – Northfield Recall 95628

Description: Lab Kit, SKU DYLAB1018; Component No. 503581

MEDLINE INDUSTRIES, LP – Northfield Recall 95628 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0355-2025
Event ID95628
Event DescriptionLab Kit, SKU DYLAB1018; Component No. 503581
Product TypeDevices
DistributionUS Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Quantity626,305 Total Kits (US only)
Recall ReasonSpecimen 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 Classification20241120
Device Code InfoUDI-DI: 40195327088393 (Case); 10195327088392 (Ea) Lots: 24IMC246
Center Classification Date20241112
Recall Initiation Date20241023
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Initial Notification Letter
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