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

Recall Z-0654-2019 — Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe kit designed for use with EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injec

U.S. FDA — Device Enforcement · Switzerland · 2018-11-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0654-2019
Date of alert: 2018-11-12
Country / jurisdiction: Switzerland
Risk level: Class II
Risk type: recall
Brand: Bracco Injeneering S.A.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 17630039300309

Reported risk: Insufficient seal on the sterile barrier of the device, compromising the sterility of the 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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