Medical device recalls Moderate risk

Degania Silicone, Ltd. recalls Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monito…

Recall date
December 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0809-2020
FDA classification
Class II
Brand / firm
Degania Silicone, Ltd.
Sold / distributed
US Distribution to IL

Why it was recalled

Temperature deviation did not meet release specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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