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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 9, 2021 · Data as of Sep 19, 7:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.