Z-3205-2018 Class II Terminated
FDA device recall Z-3205-2018 was initiated by COVIDIEN LLC on Jul 11, 2018 and is designated Class II. 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. The recall status is terminated (terminated Aug 3, 2020). Affected quantity: 27515 total.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 26, 2018
- Initiation Date
- Jul 11, 2018
- Termination Date
- Aug 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27515 total
Product Description
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
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.
Distribution Pattern
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.
Code Information
1733152764 1806451564
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3205-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026