Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 96 custom procedure trays because the included light gloves can split, breaking the sterile field.
What this means for you
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 medical device defect that breaks the sterile field, creating a risk of infection or harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 96 kits of custom procedure trays, identified by Item Number 800559001 and code 030203A. The affected products are sterile trays labeled for Head & Neck procedures at Childrens Santa Rosa, with an expiration date of December 22, 2017.
The recall was initiated because the trays contain a component, a light glove, that can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for medical procedures.
The affected trays were distributed in the United States to locations in California and Texas. Healthcare facilities that received these trays should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 96
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)
- 030203A Exp Date 2017-12-22
Distribution
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 →Related recalls
Same manufacturer · Resource Optimization & Innovation Llc
See all →- HighFDA recalls Regard IV Start Kit component over safety issue
FDA (Devices) · 2022-04-27
- ModerateResource Optimization Recalls Regard Migrating Indicator Strips for Malfunction
FDA (Devices) · 2020-08-05
- HighResource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard Custom Surgical Packs Due to Label Error
FDA (Devices) · 2017-11-29
Same hazard · sterile field breach
See all →- HighFDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk
FDA (Devices) · 2017-04-05
- HighFDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk
FDA (Devices) · 2017-04-05
- HighRecall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
FDA (Devices) · 2017-04-05
- HighRecall of Regard Sterile Hip Shoulder Procedure Kits Due to Glove Defect
FDA (Devices) · 2017-04-05
- HighRecall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
FDA (Devices) · 2017-04-05