Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation Llc is recalling 71 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 involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 71 custom procedure trays, identified as Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa. The affected units were distributed in the United States to locations in California and Texas.
The recall was initiated because the trays contain a light glove component that 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 source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 71
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 (3)
- 029238B Exp Date 2017-03-30
- 030816B Exp Date 2017-11-30
- 034258B Exp Date 2018-04-30
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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