FDANovember 12, 2018device
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¿+ Injecto...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
What to do
FDA enforcement status: Terminated
Brands named
bracco injeneeringbracco
UPCs
17630039300309
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAE-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-012018-03-08
- FDAE-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-012015-05-27
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