Recall Z-3054-2020— Medline Industries Inc

Name: FDA recall Z-3054-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-28

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2020-07-28, terminated 2023-02-13. It names one FDA 510(k) clearance: K072892. Product: Control, Calibrator Verified, Triage BNP, Model ALR88755. Reason: Product was shipped with refrigeration (ice) instead of frozen (dry ice)..

Recalling firm: Medline Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2020-07-28
Terminated: 2023-02-13
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5Biosite Incorporated·cleared 2007-12-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Control, Calibrator Verified, Triage BNP, Model ALR88755

Reason for recall

Product was shipped with refrigeration (ice) instead of frozen (dry ice).

Data sourced from openFDA. This site is unofficial and independent of the FDA.