Agency classClass IIOur severity:High FDA (Devices)·Z-1618-2017·Announced 2017-04-05

Recall of Pediatric Cardiac Catheterization Trays Due to Glove Splitting

Resource Optimization & Innovation LLC is recalling 27 pediatric cardiac catheterization 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 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 for medical devices with potential for harm but no confirmed adverse events.

Plain-English summary

Resource Optimization & Innovation LLC is recalling 27 kits of Regard Pediatric Card Cath trays (Item Number 800555002, Sterile, HT0644B). The recall affects specific lots with expiration dates of August 23, 2018, and October 10, 2018. These products were distributed in the United States to locations in California and Texas.

The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for sterile medical procedures.

Healthcare facilities that have received these specific trays should stop using them and contact the recalling firm for instructions on how to return or dispose of the affected products.

The recalled product

Product: Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Trays
Hazard: sterile-field-breach
Affected units: 27

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 (2)

037622B Exp Date 2018-08-23
038777B Exp Date 2018-10-10

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