Pentron Clinical Metrex Research recall: Labeling Error
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and…
Why was Pentron Clinical Metrex Research recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number Lot Number 4511 201008270110
- Product
- Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and…
- Recalling firm
- Metrex Research, LLC.
- Quantity
- 3,348 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
- Recall date
- December 5, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)