Bard Access Systems: Medical Device Recall in 2015 - (Recall #: Z-1560-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 13, 2015

Date Posted: May 6, 2015

Recall Number: Z-1560-2015

Event ID: 70834

Reason for Recall:

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.

Status: Terminated

Product Quantity: 700 units

Code Information:

Lot D430107

Distribution Pattern:

US Distribution to states of: GA and MN.

Voluntary or Mandated:

Voluntary: Firm initiated