Recall of Regard Custom Procedure Trays Due to Light Glove Splitting
Resource Optimization & Innovation LLC is recalling 150 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 breaks the sterile field, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 150 kits of Regard custom procedure trays, Item Number 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa. The recall is due to a defect in a component included in the trays, specifically a light glove.
The light gloves 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 the code 033783C and an expiration date of 2017-08-30.
The product was distributed in the United States to locations in California (LA) and Texas (TX). Consumers and healthcare facilities should stop using these trays and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 150
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)
- 033783C Exp Date 2017-08-30
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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