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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63583

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

Open FDA event record

Event summary

Timeline bucket
September 20, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Metrex Research, 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

Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.

Z-0444-2013
Recall number
Z-0444-2013
Initiated
September 20, 2011
Classification
Class II
Status
Terminated
Recalling firm
Metrex Research, LLC.
Quantity
3,348 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).

Code information

Part Number Lot Number 4511 201008270110

Distribution pattern

Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.