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

Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, 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 jug — recall Z-0179-2019

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-0179-2019
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)
00816203022059
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.