Agency classClass IIOur severity:Severe FDA (Devices)·Z-1646-2017·Announced 2017-04-05

FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Hazard

Resource Optimization & Innovation LLC is recalling 274 sterile custom procedure trays 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 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 an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices that compromise sterility, are categorized as Severe.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 274 units of Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn custom procedure trays. The recall was initiated by Resource Optimization & Innovation LLC.

The recall is due to a defect in a light glove component included in the trays. The manufacturer reported that the glove can split during application to a light handle, which breaks the sterile field. This defect poses a risk of contamination during surgical procedures.

The affected products were distributed in the United States to locations in Louisiana and Texas. The specific lot codes and expiration dates for the recalled items are 029922D (Exp 2017-10-30), 031037D (Exp 2017-12-30), and 032865D (Exp 2018-3-30). Healthcare facilities should stop using these trays and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Trays
Hazard: sterile-field-breach
contamination
Affected units: 274

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)

029922D Exp Date 2017-10-30
031037D Exp Date 2017-12-30
032865D Exp Date 2018-3-30

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