Reported Sep 25, 2013 · Terminated

POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system…

Access Scientific 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: Access Scientific Inc · 3910 Sorrento Valley Blvd Ste 200 · San Diego, CA · 92121-1419

Is this the product you have?

  • POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
Lot codes and dates
  • Lot no. I666473
Amount recalled
160 units

Where it was sold

Why it was recalled

Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 24, 2013 · Data as of Sep 19, 6:51 PM UTC

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