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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72667

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

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Event summary

Timeline bucket
November 04, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Edwards Lifesciences, LLC

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

Thin-Flex Venous Cannula, Model Number:TF292902A

Z-0398-2016
Recall number
Z-0398-2016
Initiated
November 04, 2015
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
8,915 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.

Code information

Lot No: 59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239 60106398 59545464 59846864 60113045 59580433 59883622 60121142 59608030 59931290 60172116 59649580 59963196 60181079

Distribution pattern

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Saudi Arabia, Sweden, Singapore, Thailand and South Africa.