Reported Jan 22, 2020 · Terminated

Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346)…

Degania Silicone, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Degania Silicone, Ltd. · Degania Bet · Dganya Bet · N/A

Is this the product you have?

  • Medline Thermistor Foley Catheter 14 FR 5-10 ml
  • non sterile Catalog Number102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage
Lot codes and dates
  • Lot NumberV18046701
Amount recalled
2080 units

Where it was sold

Why it was recalled

Temperature deviation did not meet release specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 22, 2020 · Data as of Sep 19, 5:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.