Coviden Recalls Defective Temperature Sensing Foley Catheters
Coviden is recalling specific sterile Foley catheter trays because the temperature sensors may display lower body temperature readings than the patient's actual temperature.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (inaccurate temperature monitoring) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Coviden LLC is recalling 27,515 units of the 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Tray with Cath-Secure Plus, Sterile (Item Code P4P16XTSD). The recall is due to a defect in the temperature sensor catheters, which may display a lower body temperature measurement than the patient's actual temperature.
The affected products were distributed to healthcare facilities in California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, and Washington. The recall includes specific lot codes: 1724157464, 1726253464, 1730452764, 1800353664, 1732650264, 1733152664, 1800353664, 1801652764, and 1804350264.
Healthcare providers should stop using the affected products and contact Coviden for instructions on return or replacement. Patients who have used these devices should consult their healthcare provider if they have concerns regarding their temperature readings.
The recalled product
- Product
- 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
- Manufacturer
- COVIDIEN LLC
- Category
- Medical Device — Catheters
- 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 (8)
- 1724157464
- 1726253464
- 1730452764
- 1800353664
- 1732650264
- 1733152664
- 1801652764
- 1804350264
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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Same hazard · inaccurate temperature reading
See all →- HighDover Foley Catheters Recalled for Temperature Sensor Inaccuracy
FDA (Devices) · 2020-05-20
- HighDegania Foley Temperature Sensor Catheters Recalled for Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
- ModerateFoley Catheter with Temperature Sensor Recalled for Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
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