FDAMarch 13, 2015device
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 injecti...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
bard access systemsbardbard access
Recall history
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