Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves
Resource Optimization & Innovation LLC is recalling 96 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 (loss of 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 96 kits of Regard custom procedure trays, Item Number 800413003, Sterile, CV0482C - Vascular PK - Spohn. The recall is due to a defect in a component included in the trays: a light glove 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.
The affected product has the code 027502C and an expiration date of 2017-08-17. The distribution pattern for these units was limited to the United States, specifically to locations in California (LA) and Texas (TX). The agency has classified this recall as Class II.
Healthcare facilities and consumers who have these specific trays should stop using them immediately. The primary risk associated with this defect is the loss of sterility during a procedure, which can compromise patient safety. Users should contact the recalling firm for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 96
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)
- 027502C Exp Date 2017-08-17
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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