Recall of Spohn Arthroscopy Kits Due to Splitting Light Glove Component
Resource Optimization & Innovation LLC is recalling 36 sterile arthroscopy kits 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 risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 36 kits of Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn. The recall involves custom procedure trays that contain a light glove component. The affected products have the code 027617B and an expiration date of 2017-08-17.
The recall was initiated because the light glove component can split during application to a light handle. This failure can break the sterile field, which is a critical safety requirement for surgical procedures.
The affected products were distributed in the United States to locations in California (LA) and Texas (TX). No specific injuries or illnesses have been reported in the source text. Users of these products should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 36
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)
- 027617B Exp Date 2017-08-17
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