Recall Z-2043-2020— Medline Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medline Industries Inc, initiated 2019-05-28, terminated 2023-01-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Loose silicone particulate was found to be present on the shaft of the silicone catheters..
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-28
- Terminated
- 2023-01-30
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.