Z-1560-2015Class II

PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is...

Name: Z-1560-2015 PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is...
Creator: Bard Access Systems
Published: 2015-03-13
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2015-03-13 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems began a recall of 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... on 2015-03-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1560-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Posted: 2015-04-30
Terminated: 2015-06-24
Recalling firm: Bard Access Systems, Inc.
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.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The firm, Bard, sent an "URGENT: Notification-Potential Incorrect Infusion IFU Label for PowerLoc MAX Safety Winged Infusion Set (SWIS)" letter dated March 25, 2015 to its customers. The letter described the product, problem and actions taken. The firm has corrected the cause of the issue and all future lots will be manufactured with the correct maximum flow rate of 2mL/second. Customers may return for a replacement or keep items. Please direct any return requests and questions to our coordinator at 801-522-5640.
Quantity in commerce: 700 units
Distribution: US Distribution to states of: GA and MN.
Product codes and lots: Lot D430107

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1560-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1560-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-30

Product code FPA

K073050Class IISafestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. / cleared 2008-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)