Recall of Sterile Robotic Laparoscopic Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 92 sterile robotic laparoscopic 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 risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential for significant harm but no confirmed adverse events.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 92 kits of sterile robotic laparoscopic procedure trays (Item Number: 800599001, GS0694A). The recall affects specific lots with expiration dates ranging from October 30, 2017, to April 26, 2018. The product was distributed in the United States to facilities in Louisiana 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.
No specific instructions for consumers are provided in the source text, as this is a medical device recall affecting healthcare facilities. Healthcare providers should stop using the affected trays and contact the recalling firm for further instructions.
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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