Agency classClass IIOur severity:High FDA (Devices)·Z-1644-2017·Announced 2017-04-05

Recall of Regard Sterile Lap Chole Procedure Kits Due to Glove Defect

Resource Optimization & Innovation LLC is recalling 2,016 sterile lap chole 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 involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Resource Optimization & Innovation LLC is recalling 2,016 units of the Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn. These are custom procedure trays distributed to locations in California and Texas.

The recall is being conducted because the trays contain a light glove component that has been recalled by the manufacturer. This component can split during application to a light handle, which breaks the sterile field. The affected lots have expiration dates ranging from August 14, 2017, to May 3, 2018.

Healthcare facilities that have received these kits should stop using them and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Kits
Hazard: sterile-field-breach
infection-risk
Affected units: 2,016

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 (6)

027525B Exp Date 2017-08-14
028915B Exp Date 2017-10-19
030195B Exp Date 2017-12-21
031255B Exp Date 2018-01-29
032688B Exp Date 2017-09-30
033330B Exp Date 2018-05-03

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 →

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Same hazard · sterile field breach