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

Recall Z-1965-2021 — Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547

U.S. FDA — Device Enforcement · United States · 2021-05-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1965-2021
Date of alert
2021-05-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Edwards Lifesciences, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
63598812
Reported risk: There is a potential that the pressure tubing may detach from the blood sampling system
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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