—#204219

Product

BLOOD CULTURE KIT, REF DYNDH1647B

FDA product code: OIB — Blood And Urine Collection Kit (Excludes Hiv Testing)
Device class: Class 1
Medical specialty: Pathology
Affected lot / code info: UDI/DI 40195327267002 (case), 10195327267001 (unit): Lot Numbers: 23CMH028, 23CMD954

Why it was recalled

This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 11/01/2023 via email. The notice explained the issue and requested that the destruction of the affected kits. Consignees were also instructed to notify all parties if the kits were transferred.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the state of California.

Timeline

Recall initiated: 2023-11-01
Posted by FDA: 2023-11-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204219. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.