Covidien Recalls P400 Temperature Sensor Catheters Due to Measurement Defect
Covidien is recalling P400 temperature sensor catheters because they 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 specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for P400 PREM U/M 16FR TMPSNS temperature sensor catheters, Item Code P4P16TS, manufactured by Covidien LLC. The recall involves 27,515 units of the product.
The defect involves the temperature sensors potentially displaying a lower body temperature measurement than the patient's actual temperature. This inaccuracy could affect clinical monitoring and decision-making.
The affected products were distributed to healthcare facilities in the following U.S. states: 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. Healthcare providers should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS
- Manufacturer
- COVIDIEN LLC
- Hazard
- 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)
- 1814906864
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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