Z-0809-2020Class II

Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code...

Name: Z-0809-2020 Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code...
Creator: Degania Silicone, Ltd.
Published: 2019-12-02
License: https://open.fda.gov/license/

Degania Silicone, Inc. / initiated 2019-12-02 / Terminated / root cause: manufacturing process

FDA source

Degania Silicone, Ltd. began a recall of Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature... on 2019-12-02. FDA classified it as Class II and gives the reason as "Temperature deviation did not meet release specifications". 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-0809-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-02
Posted: 2020-01-13
Terminated: 2020-10-22
Recalling firm: Degania Silicone, Inc.
Product: Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
Product code: EZL Catheter, Retention Type, Balloon
Reason for recall: Temperature deviation did not meet release specifications
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Q Medical Degania issued an "URGENT FIELD SAFETY NOTICE" letter dated 02-DEC-2019 via email, the letter states reason for recall, health risk and action to take: 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. Please promptly return the completed Recall Response form to Degania Silicone by e-mail: [email protected]. 4. The disposition of the recalled goods should be scrap. We would ask you to destruct the goods at your facility and send us the Scrap confirmation letter. Should you have any questions about this subject, please contact Degania Silicone: Degonia Silicone ltd. Degania Bet, 1513000, ISRAEL Katia Kayam, Customer complaints Officer, Tel: +972-529532059 E-mail: [email protected]
Quantity in commerce: 2080 units
Distribution: US Distribution to IL
Product codes and lots: Lot Number: V18046701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0809-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0809-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-13

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)