Recalls / —

—#190676

Product

Michels Transport Medium, 20ML Prefilled Cont

FDA product code

NNI — Container, Specimen, Non-Sterile

Device class

Class 1

Medical specialty

Pathology

Affected lot / code info

Model Number: AZSES3270, all lots with expiration date range of 08/28/2021 through 09/03/2023

Why it was recalled

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Root cause (FDA determination)

Process control

Action the firm took

Medline notified customer through first class mail on about 12/01/2021, via letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock and quarantine affected devices, return the completed provided response form indicating affected product on hand and destroyed, and to notify customers if affected product was further distributed. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.

Timeline

Recall initiated

2021-12-01

Terminated

2023-02-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #190676. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.