Recall Z-0112-2018— Medline Industries Inc

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2017-10-10, terminated 2020-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8. Reason: Products labeled as sterile were distributed prior to sterilization.

Recalling firm
Medline Industries Inc
Classification
Class II
Status
Terminated
Initiated
2017-10-10
Terminated
2020-08-04
Firm location
Northfield, IL, United States

Product description

MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8

Reason for recall

Products labeled as sterile were distributed prior to sterilization

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