Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 54 kits of Regard sterile 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 is classified as FDA Class II and involves a risk-of-harm product (breaking the sterile field) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 54 kits of Regard sterile custom procedure trays (Item Number: 800526002, ET0610B - Head and Neck - Westover Hills). The recall involves specific lots with expiration dates of April 21, 2018, and June 6, 2018. The product was distributed in the United States to locations in Louisiana 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 procedure trays should stop using them immediately and contact the recalling firm for instructions on return or disposal. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 54
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)
- 033059B Exp Date 2018-04-21
- 034067B Exp Date 2018-06-06
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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