Agency classClass IIOur severity:Severe FDA (Devices)·Z-1668-2017·Announced 2017-04-05

Resource Optimization Recalls Sterile Custom Procedure Trays Due to Glove Splitting

Resource Optimization & Innovation LLC is recalling 24 sterile custom procedure trays because a light glove component can split during application, 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). Breaking a sterile field is a significant safety hazard.

Plain-English summary

Resource Optimization & Innovation LLC is recalling 24 kits of Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper. The affected product is a custom procedure tray containing a light glove component. The recall is limited to units with code 037441C and an expiration date of 2018-08-15.

The recall was initiated because the light glove component can split during application to a light handle. This failure breaks the sterile field, which is a critical safety requirement for sterile medical procedures. The agency has classified this recall as Class II.

The affected products were distributed in the United States to locations in Louisiana and Texas. Users of these medical devices should stop using the affected trays and contact the recalling firm for further instructions.

The recalled product

Product: Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Trays
Hazard: sterile-field-breach
Affected units: 24

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)

037441C Exp Date 2018-08-15

Distribution

Distributed in 2 states:

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.

See all 135 products in this recall →

Same manufacturer · Resource Optimization & Innovation Llc

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Same hazard · sterile field breach