Agency classClass IIOur severity:High FDA (Devices)·Z-1554-2017·Announced 2017-04-05

Recall of Regard Sterile C Section Packs Due to Glove Splitting

Resource Optimization & Innovation LLC is recalling 320 sterile C Section Packs 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 sterile medical device where a defect (glove splitting) breaks the sterile field. This creates a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Resource Optimization & Innovation LLC is recalling 320 units of Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis. The affected products are sterile procedure trays distributed in the United States to locations in Louisiana and Texas. The recall involves specific lots with expiration dates of August 5, 2018, September 19, 2018, and December 14, 2018.

The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This splitting action breaks the sterile field, which is a critical safety requirement for surgical and sterile procedures. The manufacturer identified the defect and is recalling the product to prevent potential contamination or infection risks associated with a compromised sterile environment.

Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. Users should check their inventory for the item number 800036005 and the specific expiration dates listed above. If the product is found, it should be quarantined and returned to the distributor or manufacturer according to their instructions.

The recalled product

Product: Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Trays
Hazard: sterile-field-breach
infection-risk
Affected units: 320

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)

037143E Exp Date 2018-08-05
038259E Exp Date 2018-09-19
040326E Exp Date 2018-12-14

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