Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87406

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

Open FDA event record

Event summary

Timeline bucket
June 04, 2021
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Eight Medical International BV

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

Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.

Z-2005-2021
Recall number
Z-2005-2021
Initiated
June 04, 2021
Classification
Class I
Status
Terminated
Quantity
22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.

Code information

UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686

Distribution pattern

US Nationwide, Colombia, and Dubai.

Field note

Send feedback

We'll only use this to respond to your feedback.