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

Recall Z-0181-2018 — ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

U.S. FDA — Device Enforcement · United States · 2017-06-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0181-2018
Date of alert: 2017-06-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Arrow International Inc
Product category: device
Product type: Devices

Reported risk: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

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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