Recall of Pediatric Procedure Trays Due to Light Glove Splitting
Resource Optimization & Innovation LLC is recalling 430 sterile pediatric 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 medical device where a defect (glove splitting) breaks the sterile field, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 430 kits of Regard Pediatric Basic procedure trays (Item Number: 800554003). The recall involves specific lots with expiration dates of October 26, 2017, January 12, 2018, and March 21, 2018. These sterile trays 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 breaks 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, 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: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 430
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)
- 029078C Exp Date 2017-10-26
- 030847C Exp Date 2018-01-12
- 030847C Exp Date 2018-03-21
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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