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

Recall Z-2463-2021 — BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & SmartSite EXT SET, REF:

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

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2463-2021
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): 20025968

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.

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