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Terminated

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.

FDA Recall Z-0654-2019 · Posted None

Recalling FirmBracco Injeneering S.A.
Recall StatusTerminated
Product CodeDXT
Date Initiated2018-11-12
Date Terminated2020-04-15
Product Quantity33,350 packs (667 cases)

Reason for Recall

Insufficient seal on the sterile barrier of the device, compromising the sterility of the device

Firm 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].

Root Cause

Packaging process control

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K933846ANGIOGRAPHY SYRINGE KITSAngiodynamics, Div. E-Z-Em, Inc. · 1994-12-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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