Metrex Research, LLC.: 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

Is my product affected?

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.

• UPC 201008270110

Check against the official notice below — it lists the full affected range.

What happened

Metrex Research, LLC is recalling Pinnacle Cure Sleeve protective barriers due to a labeling error. Boxes labeled as part number 4511, which should contain sleeves fitting 11mm light guides, actually contain sleeves that fit 7mm or 8mm light guides (part number 4500). The recall affects 3,348 units with lot number 201008270110 that were distributed worldwide in the USA, Australia, Canada, and Europe.

The source does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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).

Details from the source

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). Distribution: Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe. Quantity: 3,348 units Lot/code info: Part Number Lot Number 4511 201008270110

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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