FDAClass IISeptember 26, 2018

Temp Sense Silicone 14fr5cc2w recall

TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T

Why was Temp Sense Silicone 14fr5cc2w recalled?

The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1733850164 1805050064

Product
TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T
Recalling firm
COVIDIEN LLC
Quantity
27515 total
Distribution
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.
Recall date
September 26, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls