Z-0654-2019Class II

Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT, EmpowerCTA and...

Name: Z-0654-2019 Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT, EmpowerCTA and...
Creator: Bracco Injeneering S.A.
Published: 2018-11-12
License: https://open.fda.gov/license/

Bracco Injeneering S.A. / initiated 2018-11-12 / Terminated / root cause: packaging

FDA source

Bracco Injeneering S.A. began a recall of Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT, EmpowerCTA and EmpowerCTA+ Injector Systems SKU 017344/6720... on 2018-11-12. FDA classified it as Class II and gives the reason as "Insufficient seal on the sterile barrier of the device, compromising the sterility of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0654-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-12
Posted: 2018-12-21
Terminated: 2020-04-15
Recalling firm: Bracco Injeneering S.A.
Product: 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.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm, Bracco Injeneering, issued "URGENT: MEDICAL DEVICE RECALL" letter via third party recall firm, on 11/12/18 to customers and distributors identifying the problem, and requesting return of unused product., Complete and return the Removal Recall Response Form even if you have no recalled stock on hand. Questions: contact Stericycle at 888-759-6907 (Monday- Friday 8 a.m. to 5 p.m. Eastern Time) or [email protected].
Quantity in commerce: 33,350 packs (667 cases)
Distribution: US Nationwide Distribution
Product codes and lots: Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0654-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0654-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20

Product code DXT

K933846Class IIAngiography Syringe KitsAngiodynamics, Div. E-Z-Em, Inc. / cleared 1994-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)