# FDA recall Z-1990-2020

> **Covidien Llc** · Class II · device recall initiated 2020-04-30.

## Product

Dover  400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement,  Sterile, Product Code: P4P16TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

## Reason for recall

Temperature sensing catheters failed to meet the  established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient  body temperatures could lead to an incorrect diagnosis and insufficient treatment

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1990-2020
- **Recalling firm:** Covidien Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-30
- **Report date:** 2020-05-20
- **Termination date:** 2023-12-14

- **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-1990-2020

## Citation

> AI Analytics. FDA recall Z-1990-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1990-2020. Source: US FDA. Licensed CC0.

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