FDA recall Z-2044-2020

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.

Reason for recall

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

Distribution

US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.

Key facts

Status

Terminated

Initiation date

2019-05-28

Report date

2020-05-27

Termination date

2023-01-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2044-2020