# FDA recall Z-3208-2018

> **COVIDIEN LLC** · Class II · device recall initiated 2018-07-11.

## Product

P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS

## 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

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.

## Key facts

- **Recall number:** Z-3208-2018
- **Recalling firm:** COVIDIEN LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-11
- **Report date:** 2018-09-26
- **Termination date:** 2020-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3208-2018

## Citation

> AI Analytics. FDA recall Z-3208-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3208-2018. Source: US FDA. Licensed CC0.

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