Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 30 custom procedure trays because the included light gloves 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 is classified as FDA Class II and involves a risk of breaking the sterile field, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 30 custom procedure trays (Item Number: 880323002, Sterile, LD0754B - C Section - OSU). The recall is due to a defect in a component, specifically a light glove, which can split during application to a light handle. This failure breaks the sterile field.
The affected product is identified by code 037321B with an expiration date of 2018-08-12. The distribution pattern indicates US distribution to Louisiana and Texas. The agency classifies this as a Class II recall.
Healthcare facilities and consumers who have these specific trays should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU
- 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)
- 037321B Exp Date 2018-08-12
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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