Recall Z-1249-2021— Medline Industries Inc

Name: FDA recall Z-1249-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-25

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2021-01-25, terminated 2023-01-09. It names one FDA 510(k) clearance: K853776. Product: RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.. Reason: Product was compromised during shipment..

Recalling firm: Medline Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2021-01-25
Terminated: 2023-01-09
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K853776 — MSI-HB HEMOGLOBIN CONTROLMedical Specialties, Inc.·cleared 1985-09-19

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

RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.

Reason for recall

Product was compromised during shipment.

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