Recall Z-0554-2022— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0554-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-01

Class II · Terminated

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2021-12-01, terminated 2023-01-09. It names one FDA 510(k) clearance: K960996. Product: HARDY DIAGNOSTICS CatScreen, 25dsk/vial. Reason: Product stored incorrectly in temperature controlled setting instead of refrigeration..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Terminated
Initiated: 2021-12-01
Terminated: 2023-01-09
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K960996 — M. CAT BUTYRATE DISKHardy Diagnostics·cleared 1996-04-18

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

HARDY DIAGNOSTICS CatScreen, 25dsk/vial

Reason for recall

Product stored incorrectly in temperature controlled setting instead of refrigeration.

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