Recall of Regard Custom Procedure Trays Due to Sterile Field Breach
Resource Optimization & Innovation LLC is recalling 32 kits of Regard 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 medical device defect that breaks the sterile field, creating a risk of infection or harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 32 kits of Regard custom procedure trays, Item Number 800508004, Sterile, LD0586D - C Section - Jasper. The affected products have an expiration date of 2018-08-31 and a code of 038465D. The recall covers units distributed to locations in Louisiana and Texas.
The recall is being conducted 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 beyond the recall notice. Healthcare facilities should verify their inventory against the specific item number and expiration date to identify affected units.
The recalled product
- Product
- Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 32
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)
- 038465D Exp Date 2018-08-31
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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