Recall of Regard Sterile Procedure Trays Due to Splitting Glove Component
Resource Optimization & Innovation LLC is recalling 126 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 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 illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 126 kits of Regard sterile procedure trays, Item Number 800508002. The affected product is identified as LD0586B - C Section - Jasper. The recall covers specific lots with expiration dates ranging from July 13, 2017, to June 21, 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 agency has classified this as a Class II recall.
The affected products were distributed in the United States to locations in Louisiana and Texas. No specific illnesses or injuries have been reported in the source text. Users should stop using the affected trays and contact the manufacturer for further instructions.
The recalled product
- Product
- Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 126
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 (4)
- 026395B Exp Date 2017-07-13
- 027756B Exp Date 2017-08-24
- 030702B Exp Date 2018-01-05
- 034442B Exp Date 2018-06-21
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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