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

Recall Z-0528-2021 — CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epid

U.S. FDA — Device Enforcement · United States · 2020-07-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0528-2021
Date of alert
2020-07-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CME America, LLC
Product category
device
Product type
Devices
Reported risk: Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
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.