Z-1781-2020Class II
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD -
Degania Medical Devices Pvt. Ltd. / initiated 2020-03-17 / Terminated / root cause: manufacturing process
Degania Medical Devices Pvt. Ltd. began a recall of Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure... on . FDA classified it as Class II and gives the reason as "Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1781-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Degania Medical Devices Pvt. Ltd.
- Product
- Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
- Product code
- EZL Catheter, Retention Type, Balloon
- Reason for recall
- Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Root cause tag
- manufacturing process
- FDA 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: [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]
- Quantity in commerce
- 700
- Distribution
- Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
- Product codes and lots
- Lot Numbers: S18012796
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1779-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1780-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1781-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1782-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1783-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1784-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1785-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1786-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1787-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1788-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1789-2020 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.