openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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device · product 1 of 1
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
