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

Recall Z-1231-2019 — ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F

U.S. FDA — Device Enforcement · United States · 2017-01-17 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1231-2019
Date of alert
2017-01-17
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
OriGen Biomedical, Inc.
Product category
device
Product type
Devices
Reported risk: Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
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.

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