COVIDIEN Recalls Defective Temperature Sensor Catheters Due to Inaccurate Readings
COVIDIEN LLC is recalling P400 temperature sensor catheters because they 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. The hazard involves inaccurate medical measurements which pose a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
COVIDIEN LLC is recalling P400 PREM U/M 18FR TMPSNS temperature sensor catheters, Item Code P4P18TS. The recall involves 27,515 units of the product.
The FDA has classified this as a Class II recall. 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.
The affected 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. The source text does not specify specific actions for consumers or patients, as these are medical devices typically managed by healthcare providers.
The recalled product
- Product
- P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
- Manufacturer
- COVIDIEN LLC
- Category
- Medical Device — Catheters
- 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)
- 1813600164
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.
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