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

Recall Z-2454-2021 — BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E

U.S. FDA — Device Enforcement · United States · 2021-08-02 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2454-2021
Date of alert
2021-08-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CAREFUSION
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
27613203013813
Reported risk: Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
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.

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.