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

Recall Z-1095-2019 — icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consis

U.S. FDA — Device Enforcement · United States · 2019-02-21 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1095-2019
Date of alert: 2019-02-21
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: ICU Medical, Inc.
Product category: device
Product type: Devices

Reported risk: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

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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