Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation Llc is recalling 40 kits of Regard sterile custom procedure trays because a light glove component can split, breaking the sterile field.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves breaking the sterile field, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 40 kits of Regard sterile custom procedure trays, Item Number 800535002. The affected lots are identified by code 033953B with an expiration date of 2018-06-02 and code 036773B with an expiration date of 2018-07-22. These products were distributed 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.
The FDA has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected trays and contact the recalling firm for further instructions.
The recalled product
- Product
- Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 40
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)
- 033953B Exp Date 2018-06-02
- 036773B Exp Date 2018-07-22
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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