Z-2043-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- May 28, 2019
- Termination Date
- January 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
Product Description
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.
Reason for Recall
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Distribution Pattern
US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
Code Information
GTIN 40080196848837 Model DYND11553 lot 287181201.