Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 92 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 medical device defect that breaks the sterile field, creating a risk of harm (contamination) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 92 custom procedure trays, identified by Item Number 800599001 and described as 'Sterile, GS0694A - Robotic Lap - Christus Highland'. The recall affects specific lots with expiration dates ranging from October 30, 2017, to April 26, 2018. These trays were distributed in the United States to locations in Louisiana and Texas.
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. Breaking the sterile field during a procedure poses a risk of contamination.
Healthcare facilities that received these trays should stop using them and contact the recalling firm for instructions on return or disposal. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 92
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 (4)
- 030226A Exp Date 2017-10-30
- 032172A Exp Date 2018-02-28
- 032696A Exp Date 2018-03-30
- 033176A Exp Date 2018-04-26
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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