Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves
Resource Optimization & Innovation Llc is recalling 180 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 medical device where a defect can break the sterile field, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 180 kits of Regard custom procedure trays, Item Number 800524004. The affected products are sterile and were distributed to locations in Louisiana and Texas. The specific lots involved have expiration dates of March 30, 2018, and July 30, 2018.
The recall was initiated because the trays contain a component, a light glove, that can split during application to a light handle. This defect 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. The manufacturer is responsible for the recall of these defective items.
The recalled product
- Product
- Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 180
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)
- 037072D Exp Date 2018-03-30
- 038802D Exp Date 2018-07-30
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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