Coviden Temperature Sensing Foley Catheters Recalled for Inaccurate Readings
Coviden is recalling temperature sensing Foley 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' criteria for risk-of-harm products.
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 P4P16TSD. 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.
The affected 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 specific lot codes associated with the recall are 1733952664 and 1735258064.
Healthcare facilities and consumers should check their inventory for these specific item codes and lot numbers. If the product is found, it should be removed from use and returned to Coviden LLC in accordance with the recall instructions.
The recalled product
- Product
- 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
- Manufacturer
- COVIDIEN LLC
- Category
- Medical Device — Foley 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 (1)
- 1733952664 1735258064
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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