Recall of Regard Custom Procedure Trays Due to Sterile Field Compromise
Resource Optimization & Innovation Llc is recalling 436 Regard custom procedure trays because a light glove component 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 risk-of-harm product (medical device) where the defect breaks the sterile field, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 436 kits of Regard custom procedure trays (Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn). The recall is due to a defect in a light glove component included in the trays.
The light glove can split during application to a light handle. This splitting action breaks the sterile field, which is a critical safety requirement for medical procedures. The affected lots have expiration dates of April 30, 2018, and October 31, 2018.
The product was distributed in the United States to locations in Louisiana and Texas. No specific injuries or illnesses have been reported in the source text. Users should stop using the affected trays and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 436
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)
- 037464C Exp Date 2018-04-30
- 038804C Exp Date 2018-04-30
- 040546C Exp Date 2018-10-31
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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