Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 148 sterile custom 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. The hazard involves breaking the sterile field, which poses a risk of harm (infection) but the source text does not report any specific injuries or illnesses.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 148 kits of Regard sterile custom procedure trays, Item Number 800558002. The affected product is identified as OR0647B - Extremity - Childrens Santa Rosa with an expiration date of 2018-03-11 and code 032157B.
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 affected units were distributed in the United States to locations in California (LA) and Texas (TX). Users of these medical devices should stop using the affected trays and contact the recalling firm for further instructions.
The recalled product
- Product
- Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 148
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)
- 032157B Exp Date 2018-03-11
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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