NNZClass I

System, Urine Drainage, Closed, For Non-indwelling Catheter, Non-sterile

Gastroenterology, Urology · 21 CFR 876.5250

Urine collector and accessories; see product code EYZ.

MDR events4All time

Recalls1All time

Registered firms34Currently listed

510(k) clearances0All time

Recent MDR events

4 adverse event reports on file

AZURE XT DR MRI SURESCANJan 12, 2023
MalfunctionMedtronic Puerto Rico Operations Co.3004209178-2023-00502
PENROSE DRAINS STERILE LATEXNov 10, 2022
MalfunctionMedline Industries, Lp15770367
MEDLINE PENROSE DRAINAug 17, 2022
MalfunctionMedline Industries, Lp - NorthfieldMW5111567
URI DRAIN IND W/STRAPMar 5, 2013
OtherCovidien Lp, Formerly Registered As Kendall Kenmex9612030-2013-00005

Event type breakdown

Malfunction3

Other1

Most-reported manufacturers

Covidien Lp, Formerly Registered As Kendall Kenmex1 Medline Industries, Lp1 Medline Industries, Lp - Northfield1 Medtronic Puerto Rico Operations Co.1

Recalls

1 recall events for this product code

Customed, Inc
TerminatedSep 3, 2015
UNIVERSAL DRAINAGE TRAY CUSTOMED 20/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2553-2015 · View FDA record ↗

Registered firms

34 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.