Medline Thermistor Foley Catheter Recalled for Temperature Deviation
Degania Silicone is recalling 2,080 units of Medline Thermistor Foley Catheters because temperature readings did not meet release specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a specification deviation without reported harm, fitting the 'Moderate' criteria for low-risk or precautionary issues.
Plain-English summary
Degania Silicone, Ltd. is recalling 2,080 units of Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile (Catalog Number: 102201101463MD, Lot Number: V18046701). The recall was initiated because the temperature deviation did not meet release specifications. These devices are used to monitor urinary output and bladder temperature in addition to facilitating urine drainage.
The affected units were distributed in the United States to Illinois. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers should stop using the affected catheters and contact the recalling firm for instructions on return or replacement. No specific instructions for end-users are provided in the source text beyond the standard recall notification.
The recalled product
- Product
- 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.
- Manufacturer
- Degania Silicone, Ltd.
- Hazard
- Affected units
- 2,080
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: V18046701
Distribution
Distributed in 1 state:
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