FDA Recalls 460 Sterile Lap Chole Procedure Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 460 sterile lap chole procedure kits 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 460 kits of Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills. The recall involves specific lots with expiration dates of 2018-09-20 and 2018-11-01. The product was distributed in the United States to locations in Louisiana and Texas.
The recall was initiated because the custom procedure 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.
Healthcare facilities that have received these kits should stop using them immediately and contact the recalling firm for instructions on return or disposal. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 460
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 (2)
- 038284E Exp Date 2018-09-20
- 039282E Exp Date 2018-11-01
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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