Pentron Clinical Metrex Research — Class II medical device recall Z-0444-2013
Terminated recall by Metrex Research, LLC., reported 2012-12-05, distributed nationwide. The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which f
| Recall number | Z-0444-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Metrex Research, LLC., Romulus, MI, United States |
| Recall initiated | 2011-09-20 |
| Classified | 2012-11-27 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2012-11-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 3,348 units |
| Reason classes | labeling |
| Lot numbers | 201008270110, 4511 |
| Model numbers | 201008270110, 4511 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0444-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.