Exact FDA event identifier

Event 80295

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

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Event summary

Timeline bucket: April 09, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Cenorin, 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

HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization

Z-2288-2018

Recall number: Z-2288-2018
Initiated: April 09, 2018
Classification: Class II
Status: Terminated
Recalling firm: Cenorin, LLC
Quantity: 14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.

Code information

Serial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610

Distribution pattern

Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan