Z-3206-2018Class II

400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile...

Name: Z-3206-2018 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile...
Creator: Covidien Llc
Published: 2018-07-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-07-11 / Terminated / root cause: manufacturing process

FDA source

COVIDIEN LLC began a recall of 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD on 2018-07-11. FDA classified it as Class II and gives the reason as "The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3206-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-11
Posted: 2018-09-20
Terminated: 2020-08-03
Recalling firm: Medtronic, Inc.
Product: 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
Product code: KOD Catheter, Urological
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 7/11/18, an Urgent Medical Device Recall letter was distributed to customers. The letter instructed customers to do the following: 1. Please quarantine any unused product of the Covidien item codes and lot numbers listed above (see Attachment A to locate). 2. If you have distributed any of the affected Covidien catheters or kits, then please promptly forward a copy of this letter to those recipients. 3. All unused product of affected item codes and lot numbers must be returned. 4. Please return unused affected product as explained below. You must complete the Recalled Product Return Form (Attachment B) regardless of whether or not you have inventory of affected product.
Quantity in commerce: 27515 total
Distribution: The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
Product codes and lots: 1733952664 1735258064

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3206-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3203-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-3204-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-3205-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-3206-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-3207-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-3208-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20

Product code KOD

K933400Class IIKendall Curity 100% Silicone Foley Catheter W/temperature SensorKendall Healthcare Products Co. Div.Of Tyco Health / cleared 1993-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)