FDA Medical Device Recalls (openFDA)
Degania Medical Devices Pvt. Ltd.: Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
- Recall number
- Z-1782-2020
- Recalling firm
- Degania Medical Devices Pvt. Ltd.
- Product
- Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
- Status
- Terminated
- Initiated
- 2020-03-17
- Posted
- not on file
- Terminated
- 2024-10-25
- Reason
- Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Root cause
- Nonconforming Material/Component
- Action
- An Urgent Field Safety Notice dated 3/17/20 was sent to customers. Please immediately follow the Required Customer Actions set fo rth below. 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. Please promptly return the completed Recall Response fo rm to Degania Silicone by e-mail: kkayam@qco.net. 4. The disposition of the recalled goods should be scrap. We would ask you to destruct the goods at your facil ity 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, Cust omer compla ints Officer Tel: +972-529532059 E-mail: kkayam@qco.net
- Quantity
- 16393
- Distribution
- Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
- Lot, serial or model codes
- Lot Numbers: V18022033 V18025110 V18025111 V18029225 V18029226 V19024273 V19013327 V19025875 V19016720 V19025874
- 510(k) numbers
- ["K063442"]
- PMA numbers
- not on file
- Product code
- EZL
- Firm FEI
- 3005483737
- Firm city
- Gurgaon
- Firm state
- Imt Manesar
- Firm country
- India
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
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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