Recall Z-3204-2018— COVIDIEN LLC

Name: FDA recall Z-3204-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-11

Class II · Terminated

Class II FDA medical device recall by COVIDIEN LLC, initiated 2018-07-11, terminated 2020-08-03. It names one FDA 510(k) clearance: K933400. Product: TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T. Reason: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient..

Recalling firm: COVIDIEN LLC
Classification: Class II
Status: Terminated
Initiated: 2018-07-11
Terminated: 2020-08-03
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K933400 — KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSORKendall Healthcare Products Co. Div.Of Tyco Health·cleared 1993-11-15

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

TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T

Reason for recall

The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

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