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

Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation. — recall Z-2202-2016

U.S. FDA — Device Enforcement · United States · 2016-06-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2202-2016
Date of alert
2016-06-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Arrow International Inc
Product category
device
Product type
Devices
Reported risk: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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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.