400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
Reported: September 26, 2018 Initiated: July 11, 2018 #Z-3203-2018
Product Description
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
Reason for Recall
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Details
- Recalling Firm
- COVIDIEN LLC
- Units Affected
- 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.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD. Recalled by COVIDIEN LLC. Units affected: 27515 total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3203-2018.
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