Recall of Regard Sterile Laparotomy Procedure Trays Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 30 sterile laparotomy 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 defect that breaks the sterile field, creating a risk of infection or other harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 30 kits of Regard sterile laparotomy procedure trays (Item Number: 880342004, GS0776D - Laparotomy - OSU). The recall involves units with an expiration date of 2018-12-01 and code 039908D. These products were distributed to locations 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.
Healthcare facilities that have received these specific procedure trays should stop using them and contact the recalling firm for instructions on return or disposal. Patients who have had procedures using these trays should consult their healthcare provider if they have concerns about the integrity of the sterile field during their surgery.
The recalled product
- Product
- Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 30
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)
- 039908D Exp Date 2018-12-01
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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