Recall record at a glance
| Official record | Z-2782-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Degania Silicone, Ltd. |
| Report date | Sep 26, 2018 |
| Recall initiation date | Jun 21, 2018 |
| Quantity | 34627 |
| Location | Dganya Bet, N/A, Israel |
Official product description
Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
Why the product was recalled
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Distribution information
Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.