Recall of Regard sterile procedure trays due to glove splitting risk
Resource Optimization & Innovation LLC is recalling 46 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.
What this means for you
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, and the hazard involves breaking the sterile field, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 46 kits of Regard sterile procedure trays (Item Number: 800535001). The affected products are identified by lot codes 029663A, 031173A, and 032155A, with expiration dates ranging from October 30, 2017, to February 28, 2018. These kits were distributed in the United States 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, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
Healthcare facilities that have received these specific kits should stop using them immediately and contact the recalling firm for instructions on return or disposal. Patients who have already had procedures using these trays should contact their healthcare provider if they have concerns about the integrity of the sterile field during their treatment.
The recalled product
- Product
- Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 46
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 (3)
- 029663A Exp Date: 2017-10-30
- 031173A Exp Date 2018-01-25
- 032155A Exp Date: 2018-02-28
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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