FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Hazard
Resource Optimization & Innovation LLC is recalling 274 sterile custom procedure trays because a light glove component can split, breaking the sterile field.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices that compromise sterility, are categorized as Severe.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 274 units of Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn custom procedure trays. The recall was initiated by Resource Optimization & Innovation LLC.
The recall is due to a defect in a light glove component included in the trays. The manufacturer reported that the glove can split during application to a light handle, which breaks the sterile field. This defect poses a risk of contamination during surgical procedures.
The affected products were distributed in the United States to locations in Louisiana and Texas. The specific lot codes and expiration dates for the recalled items are 029922D (Exp 2017-10-30), 031037D (Exp 2017-12-30), and 032865D (Exp 2018-3-30). Healthcare facilities should stop using these trays and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 274
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)
- 029922D Exp Date 2017-10-30
- 031037D Exp Date 2017-12-30
- 032865D Exp Date 2018-3-30
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