SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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.
Reported: May 27, 2020 Initiated: May 28, 2019 #Z-2042-2020
Product Description
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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.
Details
- Recalling Firm
- Medline Industries Inc
- Units Affected
- 330
- Distribution
- US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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.. Recalled by Medline Industries Inc. Units affected: 330.
Why was this product recalled? ▼
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2042-2020.
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