FDA Device recall Z-0444-2013
Pentron Clinical Metrex Research
- FDA Device
- Class II
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class II recall of Pentron Clinical Metrex Research by Metrex Research, citing 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 fi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0444-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-20 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Metrex Research |
| Distribution | US |
Product
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.
Reason
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).
Identifiers
| code_info | Part Number Lot Number 4511 201008270110 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0444-2013%22
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