Reported Jul 15, 2020 · Terminated

PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

Smiths Medical ASD 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: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

Is this the product you have?

  • PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Lot codes and dates
  • Lot 3921849.
Amount recalled
46 kits

Where it was sold

Why it was recalled

Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.

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 Jan 25, 2021 · Data as of Sep 19, 6:48 PM UTC

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