Recall of Custom Procedure Trays Due to Splitting Light Glove Component
Resource Optimization & Innovation Llc is recalling 12 custom procedure trays because a light glove component can split, breaking the sterile field.
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 3/5 (High).
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 sterile medical device where a defect breaks the sterile field, creating a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 12 custom procedure trays, identified as Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa. The recall is due to a defect in a light glove component included in the trays.
The light glove can split during application to a light handle, which breaks the sterile field. This defect compromises the sterility of the procedure tray. The affected units have an expiration date of 2018-06-25 and code 034595B.
The recalled trays were distributed in the United States to locations in California (LA) and Texas (TX). Users should stop using these trays and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 12
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)
- 034595B Exp Date 2018-06-25
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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