Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves
Resource Optimization & Innovation LLC is recalling 10 kits of Regard 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 involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 10 kits of Regard custom procedure trays, Item Number 800508001, Sterile, LD0586A - C Section - Jasper. The recall is due to a defect in a component of the trays: a light glove that can split during application to a light handle. This splitting action breaks the sterile field, which is a critical safety requirement for medical procedures.
The affected product has an expiration date of 2017-07-06 and code 026200A. The distribution pattern indicates that the product was distributed to locations in Louisiana (LA) and Texas (TX). No specific illnesses or injuries have been reported in the source text.
Healthcare providers and consumers who have these specific trays should stop using them immediately. The manufacturer has initiated this recall to prevent the compromise of the sterile field during medical procedures.
The recalled product
- Product
- Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 10
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)
- 026200A Exp Date 2017-07-06
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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