CLASS II Device recall · Reported 22 Jan 2020 · FDA Enforcement Report
Medline Thermistor Foley Catheter 5-, non sterile recalled
Degania Silicone is recalling Medline Thermistor Foley Catheter 5-, non sterile, distributed in Illinois. The recall was initiated on 2 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0809-2020
- FDA event ID
- 84510
- Recalling firm
- Degania Silicone, Dganya Bet
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Dec 2019
- FDA classified
- 13 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Temperature Abuse
- Device type
- Heart & Vascular Devices
Timeline
| 2 Dec 2019 | Recall initiated by company | |
| 13 Jan 2020 | Classified by FDA | +42 days |
| 22 Jan 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature deviation did not meet release specifications
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to IL
Questions about this recall
Why was it recalled?
Temperature deviation did not meet release specifications
Which lots are affected?
Lot Number: V18046701
Where was it sold?
US Distribution to IL
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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