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

Recall Z-0183-2019 — ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

U.S. FDA — Device Enforcement · United States · 2018-08-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0183-2019
Date of alert
2018-08-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
OriGen Biomedical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00816203022124
Reported risk: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.