Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 55 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 recall involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 55 custom procedure trays (Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa). The recall is due to a defect in a component, a light glove, which can split during application to a light handle. This splitting action breaks the sterile field.
The affected units were distributed in the US to locations in California and Texas. The specific code information for the recalled items is 037631B with an expiration date of 2018-07-30.
Healthcare facilities should stop using these specific trays and contact the recalling firm for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 55
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)
- 037631B Exp Date 2018-07-30
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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