Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 180 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 is classified as FDA Class II and involves a risk of harm (breaking the sterile field) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 180 custom procedure trays, identified by Item Number 800548002 and labeled for Medical Center Santa Rosa. The affected trays are sterile and contain a specific component, a light glove, that has been recalled by the manufacturer.
The recall is being conducted because the light glove can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for medical procedures. The agency has classified this as a Class II recall.
The affected products were distributed in the United States to locations in California (LA) and Texas (TX). The specific lot codes associated with this recall are 034942B with an expiration date of 2018-07-08, and 037820B with an expiration date of 2018-09-01. Healthcare facilities should stop using these trays and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
- 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)
- 034942B Exp Date 2018-07-08
- 037820B Exp Date 2018-09-01
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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