Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 30 custom procedure trays because a light glove component can split, breaking the sterile field.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential for significant harm.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 30 custom procedure trays, identified by Item Number 800562001 and code 026545A. The affected trays are sterile and were distributed to facilities in Los Angeles and Texas, specifically including Children's Santa Rosa.
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for medical procedures.
Healthcare facilities and consumers who have these specific trays should stop using them immediately. The source text does not provide specific instructions for disposal or return, but users should contact the manufacturer or their medical supply provider for guidance on how to handle the recalled items.
The recalled product
- Product
- Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 30
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)
- 026545A Exp Date 2017-03-30
Distribution
Part of a larger recall action
This product is one of 135 recalled by Resource Optimization & Innovation Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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