Coviden Temperature Sensing Foley Catheters Recalled for Inaccurate Readings
Coviden is recalling temperature sensing Foley catheters that may display lower body temperature measurements than the patient's actual temperature.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Coviden LLC is recalling 27,515 units of the 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Tray with Cath-Secure Plus, Sterile, Item Code P4P14TSD. The recall affects specific lot codes 1733152764 and 1806451564.
The recall was initiated because the temperature sensor catheters may be defective and show a lower body temperature measurement than the actual temperature of the patient. This inaccuracy could potentially impact clinical monitoring.
The products were distributed to healthcare facilities in the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA. Healthcare providers should stop using the affected devices and contact Coviden for further instructions.
The recalled product
- Product
- 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
- Manufacturer
- COVIDIEN LLC
- Affected units
- 27,515
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)
- 1733152764 1806451564
Distribution
Part of a larger recall action
This product is one of 6 recalled by COVIDIEN LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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