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-0809-2020Don't want to check this manually?
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