Reported May 6, 2015 · Terminated

PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended…

Bard Access Systems

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: Bard Access Systems · 605 North 5600 West · Salt Lake City, UT · 84116-3738

Is this the product you have?

  • PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.
Lot codes and dates
  • Lot D430107
Amount recalled
700 units

Where it was sold

Why it was recalled

Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch.

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 Jun 24, 2015 · Data as of Sep 19, 5:30 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.