Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 32 kits of Regard sterile custom procedure trays because a light glove component can split during application, 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 infection or harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 32 kits of Regard sterile custom procedure trays, Item Number 800508004. The product is identified by the code 038465D and has an expiration date of August 31, 2018. The recall involves the 'C Section - Jasper' configuration.
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This splitting action breaks the sterile field, which compromises the sterility of the procedure environment.
The affected products were distributed in the United States to locations in Louisiana and Texas. No specific patient or facility names are provided in the source text. Users of these medical devices should stop using the affected trays and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 32
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)
- 038465D Exp Date 2018-08-31
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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