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

Recall Z-2776-2015 — Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

U.S. FDA — Device Enforcement · United States · 2015-07-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2776-2015
Date of alert
2015-07-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Edward Lifesciences, Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
59987950
Reported risk: Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
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.