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
- Recall Number
- Z-1782-2020
- Event Number
- 85327
- Firm
- Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India
- FEI Number
- 3005483737
- Product Code
- EZL
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 17, 2020
- Terminated
- October 25, 2024
Description
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.
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
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]
Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
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