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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64770

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

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Event summary

Timeline bucket
March 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Transonic Systems Inc

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

HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

Z-1147-2013
Recall number
Z-1147-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
195 units total (140 units Domestic, 55 units Foreign)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

Code information

Lot numbers: 102810, 010311 and 111810.

Distribution pattern

Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.