Coviden Temp Sense Silicone Catheters Recalled for Inaccurate Temperature Readings
Coviden is recalling Temp Sense Silicone catheters because they may display lower body temperature measurements 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 involves a medical device defect that could lead to incorrect clinical decisions (underestimating body temperature), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Coviden LLC is recalling Temp Sense Silicone 14FR5CC2W catheters, Item Code 50514T. The recall involves 27,515 units of the product.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient. The products were distributed to 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 instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T
- 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)
- 1733850164 1805050064
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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