Device product
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 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.
Z-2044-2020
Product summary
- Event
- Event 84791
- Status
- Terminated
- Classification
- Class II
- Quantity
- 0
- Official record key
device-enforcement:Z-2044-2020
Official wording
Reason: Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Code information: GTIN 40884389034423 Model DYND11554 lot 287181201.
Distribution pattern: US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
Derived failure modes
-
Foreign material or chemical contamination
particulate