FDA-Device2020-01-22Class II

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.

Degania Silicone, Ltd.
Hazard

Temperature deviation did not meet release specifications

Sold states
US Distribution to IL
Affected count
2080 units
Manufactured in
Degania Bet, Dganya Bet, Israel
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0809-2020

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