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

Recall Z-2806-2020 — ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various ca

U.S. FDA — Device Enforcement · United States · 2020-06-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2806-2020
Date of alert: 2020-06-19
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): 11295042

Reported risk: Sterile introducer sheath set manufactured under one lot with different expiration dates.

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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