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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81616

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 12, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bracco Injeneering S.A.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0654-2019
Recall number
Z-0654-2019
Initiated
November 12, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bracco Injeneering S.A.
Quantity
33,350 packs (667 cases)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804

Distribution pattern

US Nationwide Distribution