Medline Thermistor Foley Catheter 14 FR 5-10 ml — Class II medical device recall Z-0809-2020
Terminated recall by Degania Silicone, Ltd., reported 2020-01-22, distributed in IL. Temperature deviation did not meet release specifications
| Recall number | Z-0809-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Degania Silicone, Ltd., Dganya Bet, Israel |
| Recall initiated | 2019-12-02 |
| Classified | 2020-01-13 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2020-10-22 |
| Distributed | IL |
| Quantity | 2,080 units |
| Lot numbers | V18046701 |
| Model numbers | 102201101463MD, 55346 |
Product
Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
Reason for recall
Temperature deviation did not meet release specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0809-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.