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

Recall Z-2657-2018 — 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free wi

U.S. FDA — Device Enforcement · United States · 2017-07-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2657-2018
Date of alert: 2017-07-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ICU Medical, Inc.
Product category: device
Product type: Devices

Reported risk: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

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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