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

Recall Z-2819-2018 — HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.

U.S. FDA — Device Enforcement · United States · 2018-07-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2819-2018
Date of alert: 2018-07-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Arrow International Inc
Product category: device
Product type: Devices

Reported risk: The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.

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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