Recall Z-2154-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-2154-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-18

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-18. It names one FDA 510(k) clearance: K032065. Product: Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures. Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-05-18
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERSMedline Industries, Inc.·cleared 2003-09-22

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

Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

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