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

Recall Z-0434-2020 — Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

U.S. FDA — Device Enforcement · United States · 2019-10-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0434-2020
Date of alert: 2019-10-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cook Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00827002059764

Reported risk: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

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-0434-2020 — Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

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