Date Initiated by Firm | March 17, 2020 |
Create Date | April 23, 2020 |
Recall Status1 |
Terminated 3 on October 25, 2024 |
Recall Number | Z-1782-2020 |
Recall Event ID |
85327 |
510(K)Number | K063442 |
Product Classification |
Catheter, retention type, balloon - Product Code EZL
|
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. |
Code Information |
Lot Numbers: V18022033 V18025110 V18025111 V18029225 V18029226 V19024273 V19013327 V19025875 V19016720 V19025874 |
Recalling Firm/ Manufacturer |
Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India
|
Manufacturer Reason for Recall | Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. |
FDA Determined Cause 2 | 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 in Commerce | 16393 |
Distribution | Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = EZL
|