FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 42 sterile custom procedure trays because a light glove component can split, potentially breaking the sterile field.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the defect involves breaking the sterile field, which poses a significant risk of infection or injury, aligning with the 'Severe' criteria for structural defects or significant injury risks.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 42 sterile custom procedure trays manufactured by Resource Optimization & Innovation LLC. The affected product is identified as Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU, with an expiration date of October 11, 2018, and code 038795C.
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. The agency classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The affected units were distributed in the United States to locations in Louisiana and Texas. Healthcare facilities and consumers who possess 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: 880323003, Sterile, LD0754C - C Section - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 42
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 (1)
- 038795C Exp Date 2018-10-11
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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