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

Recall Z-2718-2017 — 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the admin

U.S. FDA — Device Enforcement · United States · 2017-05-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2718-2017
Date of alert: 2017-05-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ICU Medical, Inc.
Product category: device
Product type: Devices

Reported risk: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

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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