Recall Z-3205-2018— COVIDIEN LLC

Name: FDA recall Z-3205-2018
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: 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD. 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

400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD

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.