Empower FastLoad CT Syringe Pack -sterile disposable… recallZ-0654-2019 · Bracco Injeneering S.A. · initiated Nov 12, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bracco Injeneering S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
FDA root cause category: Packaging process control
What the company is doing
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].
Recall details
- Recall number
- Z-0654-2019
- Status
- Terminated
- Initiated by the company
- Nov 12, 2018
- Recalling firm
- Bracco Injeneering S.A.
- Quantity
- 33,350 packs (667 cases)
- Product code
- DXT
- FDA submissions
- K933846
- Distribution
- US Nationwide Distribution
Product description
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.
Code information (models, lots, serial numbers)
Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FastLoad™ CT Syringe Pack 017344Bracco Injeneering SA · Injector And Syringe, Angiographic1 recall4 reports
Other devices under the same FDA submission
5 devices cleared under K933846 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- FastLoad™ CTA Dual Syringe Pack 017354Bracco Injeneering SA · Injector And Syringe, Angiographic20 reports
- FastLoad™ CTA Dual Syringe Pack with Spikes 017355Bracco Injeneering SA · Injector And Syringe, Angiographic19 reports
- FastLoad™ CT Syringe Pack with spike 017345Bracco Injeneering SA · Injector And Syringe, Angiographic1 report
- FastLoad™ CTA Dual Syringe Pack 017346Bracco Injeneering SA · Injector And Syringe, Angiographic1 report
- FastLoad™ CTA Dual Syringe Pack with spikes 017347Bracco Injeneering SA · Injector And Syringe, Angiographic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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