Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 210 custom procedure trays because the included light gloves 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 medical device defect that breaks the sterile field, creating a risk of harm (infection) during surgery. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 210 custom procedure trays, identified as Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa. The recall was initiated because the trays contain a component, a light glove, that has been recalled by the manufacturer.
The light gloves can split during application to a light handle, which breaks the sterile field. This defect poses a risk to patient safety during surgical procedures.
The affected products were distributed in the United States to locations in California (LA) and Texas (TX). The specific lot codes are 036887C with an expiration date of 2018-07-28, and 038469C with an expiration date of 2018-09-26. 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: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 210
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)
- 036887C Exp Date: 2018-07-28
- 038469C Exp Date 2018-09-26
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.
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