Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves
Resource Optimization & Innovation Llc is recalling 240 sterile 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 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 240 sterile Regard custom procedure trays (Item Number: 800623001). The recall affects specific lots with expiration dates ranging from December 30, 2017, to March 30, 2018. The product was distributed to facilities in California and Texas, including Neuro - Medical Center Santa Rosa.
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 medical procedures.
Healthcare facilities that received these trays should stop using them and contact the recalling firm for instructions on return or disposal. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 240
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 (4)
- 031463A Exp Date 2017-12-30
- 032411A Exp Date 2018-02-28
- 032871A Exp Date 2018-03-30
- 033654A Exp Date 2018-03-30
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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