Metrex Research Recalls Pinnacle Cure Sleeves Due to Labeling Error
Metrex Research is recalling Pinnacle Cure Sleeves because boxes labeled for 11mm light guides contain sleeves for 7mm or 8mm guides.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error where the wrong size of protective sleeve was shipped, fitting the criteria for moderate severity.
Plain-English summary
Metrex Research, LLC. is recalling 3,348 units of Pinnacle Cure Sleeves, a protective barrier device intended to protect patients and healthcare workers from the transfer of microorganisms, body fluids, and particulate matter. The recall was initiated due to a labeling error.
The specific issue involves boxes labeled as Pinnacle Cure Sleeve 4511, which are intended to fit 11mm light guides. However, these boxes actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500). The affected product is identified by Part Number 4511 and Lot Number 201008270110.
The affected units were distributed worldwide, including nationwide in the USA and in Australia, Canada, and Europe. Healthcare providers and consumers should check their inventory for the specific part and lot numbers listed above and stop using the affected devices if they match the description.
The recalled product
- 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.
- Manufacturer
- Metrex Research, LLC.
- Hazard
- Affected units
- 3,348
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number Lot Number 4511 201008270110
Distribution
Distributed nationwide across the United States.
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