Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 46 custom procedure trays because the included light gloves 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 FDA classified this as a Class II recall. The hazard involves breaking the sterile field, which poses a risk of infection or other adverse health consequences, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 46 kits of custom procedure trays, specifically the Regard Item Number 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa. The affected units were distributed in the United States to locations in California and Texas. The specific lot code is 037469E with an expiration date of June 30, 2018.
The recall was initiated because the trays contain a component, a light glove, that has been recalled by the manufacturer. This component can split during application to a light handle, which breaks the sterile field. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities that have received these specific procedure trays should stop using them and contact the recalling firm for further instructions. Consumers are not directly affected by this recall, as the product is intended for professional medical use.
The recalled product
- Product
- Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- 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 (1)
- 037469E Exp Date 2018-06-30
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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