FDA Medical Device Recalls (openFDA)
Degania Silicone, Ltd.: 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.
- Recall number
- Z-2775-2018
- Recalling firm
- Degania Silicone, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2018-06-21
- Posted
- not on file
- Terminated
- 2024-10-25
- Reason
- 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
- 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: Katia@ds-il.com 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: jackie@deganiasilicone.com
- Quantity
- 500
- Distribution
- Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
- Lot, serial or model codes
- S17003407
- 510(k) numbers
- ["K063442"]
- PMA numbers
- not on file
- Product code
- EZL
- Firm FEI
- 7682
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28