Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation Llc is recalling 48 kits of Regard sterile custom procedure trays because a light glove component can split during application, 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 (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 48 kits of Regard sterile custom procedure trays, Item Number 880327005, CV0758E - Open Heart A&B - OSU. The recall involves specific lots with expiration dates of 2017-07-30, identified by codes 030249E and 031452E. The product was distributed in the United States to locations in Louisiana 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. The manufacturer recalled the component due to this risk.
Healthcare facilities and consumers who have these specific trays should stop using them immediately. Affected parties should contact the recalling firm, Resource Optimization & Innovation Llc, for instructions on how to return or dispose of the product.
The recalled product
- Product
- Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 48
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)
- 030249E Exp Date 2017-07-30
- 031452E Exp Date 2017-07-30
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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