Recall of Regard Custom Procedure Trays Due to Light Glove Splitting
Resource Optimization & Innovation LLC is recalling 25 kits of Regard 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 where a component failure can break the sterile field, posing a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 25 kits of Regard custom procedure trays, Item Number 800562002. The affected product is sterile and identified by the code 032109B with an expiration date of 2018-01-30. The trays were distributed in the United States to locations in Louisiana and Texas.
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This failure can break the sterile field, which is a critical safety standard in medical procedures.
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: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 25
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)
- 032109B Exp Date 2018-01-30
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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