Temperature sensing catheter 18FR, Catalogue Number 102203101863DO 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.
FDA Recall Z-2783-2018 · Posted None
Recalling FirmDegania Silicone, Ltd.
Recall StatusTerminated
Product CodeEZL
Date Initiated2018-06-21
Date Terminated2024-10-25
Product Quantity2461
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.
Firm 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]
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.