Recall Z-1560-2015— Bard Access Systems

Name: FDA recall Z-1560-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-13

Class II · Terminated

Class II FDA medical device recall by Bard Access Systems, initiated 2015-03-13, terminated 2015-06-24. It names one FDA 510(k) clearance: K073050. 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.. 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..

Recalling firm: Bard Access Systems
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Terminated: 2015-06-24
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K073050 — SAFESTEP MAX POWER-INJECTABLE INFUSION SETSpecialized Health Products International, Inc.·cleared 2008-01-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.