Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1560-2015 — 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 injecti

U.S. FDA — Device Enforcement · United States · 2015-03-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1560-2015
Date of alert: 2015-03-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bard Access Systems
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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