Bard Access Systems recalls PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended f…

Recall date

March 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1560-2015

FDA classification

Class II

Brand / firm

Bard Access Systems

Sold / distributed

US Distribution to states of: GA and MN.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.