Reported Dec 26, 2018 · Terminated
Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and…
Bracco Injeneering S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bracco Injeneering S.A. · Avenue De Sevelin 46 · Lausanne · N/A
Is this the product you have?
- 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¿+ Injector Systems. It is used to intravenously facilitate the administration of contrast media and flushing solutions into the human vascular systems.
- Lot codes and dates
- Lot #
- IANBL-1804 UDI(01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804
- Amount recalled
- 33,350 packs (667 cases)
Where it was sold
- Nationwide
Why it was recalled
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
This product could cause temporary or reversible health problems — stop using it.
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