Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves
Resource Optimization & Innovation LLC is recalling 120 sterile custom procedure trays because the included light gloves 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 source identifies this as an FDA Class II recall involving a sterile field breach, which poses a risk of harm (infection) but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).
Plain-English summary
Resource Optimization & Innovation LLC is recalling 120 kits of Regard custom procedure trays (Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa). The recall is due to a defect in a component of the trays: a light glove that can split during application to a light handle. This splitting action breaks the sterile field.
The affected product was distributed in the United States to locations in California (LA) and Texas (TX). The specific lots involved have expiration dates of 2018-09-06 (Code 037945B) and 2018-11-21 (Code 039741B).
Healthcare facilities and consumers should stop using these specific trays immediately. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 120
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)
- 037945B Exp Date 2018-09-06
- 039741B Exp Date 2018-11-21
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