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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