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U.S. Department of Health and Human Services

Class 2 Device Recall Empower FastLoad CT Syringe Pack

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 Class 2 Device Recall Empower FastLoad CT Syringe Packsee related information
Date Initiated by FirmNovember 12, 2018
Create DateDecember 21, 2018
Recall Status1 Terminated 3 on April 15, 2020
Recall NumberZ-0654-2019
Recall Event ID 81616
510(K)NumberK933846 
Product Classification Injector and syringe, angiographic - Product Code DXT
ProductEmpower 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 Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804
FEI Number 3004753774
Recalling Firm/
Manufacturer		 Bracco Injeneering S.A.
Avenue De Sevelin 46
Lausanne Switzerland
For Additional Information ContactKimberly Gerweck
609-5142136
Manufacturer Reason
for Recall		Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
FDA Determined
Cause 2		Packaging process control
ActionThe 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 acistmedical3021@stericycle.com.
Quantity in Commerce33,350 packs (667 cases)
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DXT
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