Recall Z-0552-2022— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0552-2022
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 2023-02-13. It names one FDA 510(k) clearance: K852969. Product: Premier Rotaclone, Rx only. 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: 2023-02-13
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K852969 — ROTACLONE ROTAVIRUS DIAGNOSTIC KITCambridge Bioscience Corp.·cleared 1985-11-05

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

Premier Rotaclone, Rx only

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.