Recall of Regard Sterile Total Knee Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 70 sterile total knee 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 involves a medical device where a defect can break the sterile field, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 70 kits of Regard sterile total knee procedure trays (Item Number: 800553002, OR0642B). The recall involves trays distributed to Medical Center Santa Rosa in California 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 surgical procedures.
The affected product has the code 034869B and an expiration date of April 30, 2018. Healthcare facilities should stop using these trays and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 70
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)
- 034869B Exp Date 2018-04-30
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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