Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0169-2018·Announced 2017-11-29

Resource Optimization Recalls Regard Custom Surgical Packs Due to Label Error

Resource Optimization & Innovation LLC is recalling 51 units of Regard Custom Surgical Packs because they contain a 3ml ChloraPrep With Tint unit with an incorrect label.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a labeling error, which fits the criteria for a moderate severity score involving minor labeling errors or low-risk contamination.

Plain-English summary

Resource Optimization & Innovation LLC (ROi) is recalling 51 units of Regard Custom Surgical Packs. These packs contain surgical instruments and accessories intended for use during a surgical procedure. The recall is being conducted because the packs contain 3ml ChloraPrep With Tint units that have incorrect labels.

The recall was initiated after ROi received a notice from BD regarding an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The error occurred at the unit level, where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. BD issued the recall notification on September 15, 2017, and ROi received it on September 18, 2017.

The affected Regard Custom Surgical Packs are identified by Item No. 800620003, Lot No. 047005C, and an expiration date of 08/15/2019. The products were distributed domestically to Texas. Consumers and healthcare providers should stop using the affected products and contact the recalling firm for further instructions.

The recalled product

Product: Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Packs
Hazard: mis-labeling
Affected units: 51

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)

Item No. 800620003
Lot No. 047005C
Exp. Date 08/15/2019

Distribution

Distributed in 1 state:

Same manufacturer · Resource Optimization & Innovation Llc

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Same hazard · mis labeling