RecallRadar

FDA Device recall Z-0112-2018

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

On 2017-11-29 the FDA classified a Class II recall of MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8 by Medline Industries, citing products labeled as sterile were distributed prior to sterilization.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0112-2018
ClassificationClass II
Statusterminated
Initiated2017-10-10
Published2017-11-29
Last updated2026-09-13 11:54 UTC
CompanyMedline Industries
DistributionFL, GA, IN, MD, NJ, TN, UT

Product

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

Reason

Products labeled as sterile were distributed prior to sterilization

Identifiers

code_infoLot 2861707008

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0112-2018%22

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