Recall of Regard Sterile Hip Shoulder Procedure Kits Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 45 sterile procedure 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 where the sterile field can be broken, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 45 kits of Regard Item Number 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills. The recall involves specific lots with expiration dates of July 30, 2018, and August 30, 2018. These kits were distributed in the United States to locations in Louisiana and Texas.
The recall is being conducted because the procedure 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 surgical procedures.
Healthcare facilities that received these kits should stop using them and contact the recalling firm for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 45
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)
- 037607D Exp Date 2018-07-30
- 039119D Exp Date 2018-07-30
- 039575D Exp Date 2018-08-30
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.
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