Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation Llc is recalling 276 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 breaking the sterile field, which is a significant safety hazard in medical settings, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 276 kits of custom procedure trays, specifically Item Number 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa. The recall is due to a defect in a component of the trays: a light glove that can split during application to a light handle.
The splitting of the glove can break the sterile field, which is a critical safety requirement for medical procedures. The affected products were distributed in the United States to locations in California (LA) and Texas (TX). The specific lot codes are 034265B with an expiration date of 2018-06-16, and 037465B with an expiration date of 2018-08-17.
Healthcare facilities and consumers who have these specific trays should stop using them immediately and contact the recalling firm for instructions on return or disposal. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 276
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)
- 034265B Exp Date 2018-06-16
- 037465B Exp Date 2018-08-17
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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