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

Recall Z-0113-2015 — Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.

U.S. FDA — Device Enforcement · United States · 2014-08-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0113-2015
Date of alert: 2014-08-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Vygon Corporation
Product category: device
Product type: Devices

Reported risk: Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.

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.

Recall Z-0113-2015 — Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.

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