Z-2775-2018Class II

Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD

Name: Z-2775-2018 Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD
Creator: Degania Silicone, Ltd.
Published: 2018-06-21
License: https://open.fda.gov/license/

Degania Silicone, Inc. / initiated 2018-06-21 / Terminated / root cause: manufacturing process

FDA source

Degania Silicone, Ltd. began a recall of Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley... on 2018-06-21. FDA classified it as Class II and gives the reason as "The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a 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-2775-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-21
Posted: 2018-09-20
Terminated: 2024-10-25
Recalling firm: Degania Silicone, Inc.
Product: Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
Product code: EZL Catheter, Retention Type, Balloon
Reason for recall: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Urgent Field Safety Notice letters were distributed to customers on 6/21/18. The letters instructed customers to perform the following: 1. Please forward this information to the immediate attention of the persons responsible for usage of the affected parts. Sub-recall must be initiated by your company to collect any distributed product from the suspected list. 2. Please fill in the attached Recall Response form and indicate the quantity of the affected product in your possession. 3. Promptly return the completed Recall Response form to Degania Silicone by e-mail: [email protected] Any affected product should be returned to Degania Facility at Rhode Island: Degania Silicone, Inc. 14 Thurber Blvd, Suite A Smithfield, RI 02917, US Contact name: Jackie Dubon e-mail: [email protected]
Quantity in commerce: 500
Distribution: Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
Product codes and lots: S17003407

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2775-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2754-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2755-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2756-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2757-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2758-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2759-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2760-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2761-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2762-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2763-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2764-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2765-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2766-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2767-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2768-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2769-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2770-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2771-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2772-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2773-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2774-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2775-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2776-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2777-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2778-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2779-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2780-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2781-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2782-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2783-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2784-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20
Z-2785-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20

Product code EZL

K063442Class IIAll Silicone Foley Catheter, 2-Way, 3-Way, with Temperature SensorDegania Silicone , Ltd. / cleared 2007-03-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)