Recall of Regard Sterile Procedure Trays Due to Glove Splitting Hazard
Resource Optimization & Innovation LLC is recalling 40 kits of Regard sterile 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 harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 40 kits of Regard sterile procedure trays (Item Number: 800535002, LD0620B - C Section - New Braunfels). The recall involves specific lots with expiration dates of June 2, 2018, and July 22, 2018.
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, compromising the sterility of the procedure.
The affected products were distributed in the United States to locations in Louisiana and Texas. Users of these specific procedure trays should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 40
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)
- 033953B Exp Date 2018-06-02
- 036773B Exp Date 2018-07-22
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.
See all 135 products in this recall →Related recalls
Same manufacturer · Resource Optimization & Innovation Llc
See all →- HighFDA recalls Regard IV Start Kit component over safety issue
FDA (Devices) · 2022-04-27
- ModerateResource Optimization Recalls Regard Migrating Indicator Strips for Malfunction
FDA (Devices) · 2020-08-05
- HighResource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard Custom Surgical Packs Due to Label Error
FDA (Devices) · 2017-11-29
Same hazard · sterile field breach
See all →- HighFDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk
FDA (Devices) · 2017-04-05
- HighFDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk
FDA (Devices) · 2017-04-05
- HighRecall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
FDA (Devices) · 2017-04-05
- HighRecall of Regard Sterile Hip Shoulder Procedure Kits Due to Glove Defect
FDA (Devices) · 2017-04-05
- HighRecall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
FDA (Devices) · 2017-04-05