FDAFDA · Food and drugs·Recall number Z-2043-2020
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
Published May 27, 2020 · Recall initiated: May 28, 2019
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
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries Inc
- Distributor
- US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
- Lot
- GTIN 40080196848837 Model DYND11553 lot 287181201.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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