Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall Z-1779-2020 · Posted None
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Recalling FirmDegania Medical Devices Pvt. Ltd.
Recall StatusTerminated
Product CodeEZL
Date Initiated2020-03-17
Date Terminated2024-10-25
Product Quantity2500
Reason for Recall
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Firm 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:
[email protected].
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: [email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution - US Nationwide distribution including state of IL and the country of 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.
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