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Recall Observatory FDA recall evidence

Device product

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.

Z-1560-2015

March 13, 2015

Class II

Product summary

Firm
Bard Access Systems
Event
Event 70834
Status
Terminated
Classification
Class II
Quantity
700 units
Official record key
device-enforcement:Z-1560-2015

Official wording

Reason: 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.

Code information: Lot D430107

Distribution pattern: US Distribution to states of: GA and MN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.