Reported Aug 25, 2021 · Completed
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Epimed International
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: Epimed International · 13958 Diplomat Dr · Farmers Branch, TX · 75234-8805
Is this the product you have?
- NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
- Lot codes and dates
- Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)
- Amount recalled
- 140 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential for stylet to protrude from the distal end of the catheter
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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