Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 280 sterile custom procedure trays because a light glove component can split during application, 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 where a sterile field breach can occur, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 280 kits of Regard sterile custom procedure trays, Item Number 800558004. The specific product configuration is OR0647D - Extremity - Childrens Santa Rosa. The affected lots have expiration dates of August 17, 2018, October 10, 2018, and November 16, 2018.
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 surgical and medical procedures.
The product was distributed in the United States to locations in California and Texas. No specific illnesses or injuries have been reported in the source text. Users of these medical devices should stop using the affected trays and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 280
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)
- 037471D Exp Date 2018-08-17
- 038772D Exp Date 2018-10-10
- 039620D Exp Date 2018-11-16
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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