Reported May 27, 2020 · Terminated
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a…
Medline Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries Inc · Three Lakes Drive · Northfield, IL · 60093
Is this the product you have?
- SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8
- Fr 3 ml - Product UsageMedline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device
- Lot codes and dates
- GTIN 40080196848837 Model DYND11553 lot 287181201.
- Amount recalled
- 0
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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