Reported Jul 29, 2020 · Terminated
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Wellspect HealthCare (Division of DENTSPLY IH AB)
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: Wellspect HealthCare (Division of DENTSPLY IH AB) · Aminogatan 1 · Molndal, N/A · N/A
Is this the product you have?
- LoFric Origo, Nelaton, 16in, FR10 urinary catheters
- Lot codes and dates
- Lot # 447123
- Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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