Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 165 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 medical device defect that breaks the sterile field, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 165 custom procedure trays, specifically the Regard Item Number 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa. The affected products were distributed in the United States to locations in California and Texas. The recall involves two specific lots with expiration dates of July 9, 2018, and November 9, 2018.
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 procedure 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 supplier for guidance on how to handle the recalled items.
The recalled product
- Product
- Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 165
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 (2)
- 034982C Exp Date 2018-07-09
- 039451C Exp Date 2018-11-09
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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