Recall of Regard Custom Procedure Trays Due to Sterile Field Breach Risk
Resource Optimization & Innovation LLC is recalling 284 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 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 284 units of Regard custom procedure trays, Item Number 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa. The affected lots have expiration dates of July 20, 2017 (code 026566A) and December 23, 2017 (code 030227A). These products were distributed in the United States to locations in California and Texas.
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This splitting action can break the sterile field, which is a critical safety requirement for surgical and procedural environments.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. The manufacturer, Resource Optimization & Innovation LLC, is responsible for the recall. Users should contact the manufacturer for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 284
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)
- 026566A Exp Date 2017-07-20
- 030227A Exp Date 2017-12-23
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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