Recall of Regard Custom Procedure Trays Due to Sterile Field Breach Risk
Resource Optimization & Innovation LLC is recalling 350 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 (medical device) where the failure of the sterile field poses a risk of infection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 350 kits of Regard custom procedure trays (Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn). The recall affects specific lots with expiration dates of July 12, 2018, September 23, 2018, and November 15, 2018. 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 failure can break the sterile field, which is a critical safety requirement for medical procedures.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. Users should contact the recalling firm, Resource Optimization & Innovation LLC, for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 350
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 (3)
- 035042B Exp Date 2018-07-12
- 038457B Exp Date 2018-09-23
- 039618B Exp Date 2018-11-15
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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