Recall of Regard Sterile Procedure Trays Due to Glove Splitting Hazard
Resource Optimization & Innovation LLC is recalling 40 kits of Regard sterile 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 involves a medical device defect that breaks the sterile field, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 40 kits of Regard sterile procedure trays (Item Number: 800535002, LD0620B - C Section - New Braunfels). The recall involves specific lots with expiration dates of June 2, 2018, and July 22, 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, compromising the sterility of the procedure.
The affected products were distributed in the United States to locations in Louisiana and Texas. Users of these specific procedure trays should stop using them and contact the recalling firm for instructions on return or disposal.
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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