Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation Llc is recalling 25 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 medical device where a defect can break the sterile field, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 25 kits of Regard sterile custom procedure trays (Item Number: 800569003, CV0659C - Open Heart A&B - Medical Center Santa Rosa). The affected lots have expiration dates of 2018-07-30 (Code 038092C) and 2018-08-30 (Code 039713C). The product was distributed in the US 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 medical procedures.
Healthcare facilities and consumers who have these specific trays should stop using them immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 25
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)
- 038092C Exp Date 2018-07-30
- 039713C Exp Date 2018-08-30
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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