Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 212 Regard sterile custom 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, posing a risk of harm (contamination/infection) even though no specific injuries are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 212 kits of Regard sterile custom procedure trays (Item Number: 800430005, LD0499E - C Section Pk - Cabrini). The affected lots have expiration dates of August 23, 2018, October 20, 2018, and November 29, 2018. The product was distributed in the United States to locations in California 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 medical procedures.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. The manufacturer has recalled the product to prevent the risk of contamination associated with a broken sterile field.
The recalled product
- Product
- Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 212
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 (3)
- 037619E Exp Date 2018-08-23
- 038962E Exp Date 2018-10-20
- 039792E Exp Date 2018-11-29
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