FDAFDA · Food and drugs·Recall number Z-1991-2020
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 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 P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Published May 20, 2020 · Recall initiated: April 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien Llc
- Distributor
- US Nationwide distribution.
- Lot
- Lot Numbers: 1828205964, 1911414164
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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