Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation Llc is recalling 90 custom procedure trays because the included light gloves can split, breaking the sterile field.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 90 custom procedure trays, identified by Item Number 800551001 and code 032891A. These trays were distributed to Medical Center Santa Rosa in California and Texas.
The recall was initiated because the trays contain a component, a light glove, that can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for surgical procedures.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items, nor does it report any illnesses or injuries resulting from the defect.
The recalled product
- Product
- Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 90
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)
- 032891A Exp Date 2018-04-13
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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