Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves
Resource Optimization & Innovation LLC is recalling 48 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 is classified as FDA Class II and involves a risk-of-harm product (broken sterile field) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 48 kits of Regard custom procedure trays, Item Number 800425, Sterile, CV0494 - Av Access PK - Spohn. The recall involves product with expiration date 2017-09-16 and code 028153.
The recall is being conducted because the trays contain a light glove component that can split during application to a light handle. This failure breaks the sterile field, which is a critical safety requirement for medical procedures.
The affected product was distributed in the United States to locations in Louisiana and Texas. Users of these specific procedure trays should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 48
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)
- 028153 Exp Date 2017-09-16
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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