Agency classClass IIOur severity:High FDA (Devices)·Z-1552-2017·Announced 2017-04-05

FDA Recalls Sterile Breast Procedure Kits Due to Glove Splitting Risk

Resource Optimization & Innovation LLC is recalling six sterile breast procedure kits because a light glove component can split, 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 3/5 (High).

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 is classified as FDA Class II. The hazard involves breaking the sterile field, which poses a risk of infection or harm during a medical procedure, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for six sterile breast procedure kits (Item Number 880321001) manufactured by Resource Optimization & Innovation LLC. The recall is due to a defect in a light glove component included in the kits.

The light glove can split during application to a light handle. This failure can break the sterile field, which is a critical safety requirement for medical procedures. The affected kits have an expiration date of August 30, 2017, and were distributed in the United States to locations in Louisiana and Texas.

Healthcare facilities and consumers who have these specific kits should stop using them immediately. The recall number is Z-1552-2017. Users should contact the manufacturer for instructions on returning or disposing of the affected products.

The recalled product

Product: Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Kits
Hazard: sterile-field-breach
infection-risk
Affected units: 6

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)

027914A Exp Date 2017-08-30

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