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

Recall Z-0051-2017 — MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

U.S. FDA — Device Enforcement · United States · 2016-09-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0051-2017
Date of alert: 2016-09-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Argon Medical Devices, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 11149662

Reported risk: The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath

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.

Recall Z-0051-2017 — MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

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