Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation Llc is recalling 16 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 risk-of-harm product where the defect (breaking the sterile field) poses a significant safety risk, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 16 kits of Regard sterile custom procedure trays (Item Number: 880327008, CV0758H - Open Heart A&B - OSU). The affected units have an expiration date of 2018-04-30 and were distributed 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.
Healthcare facilities that have received these specific trays should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 16
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)
- 036916H Exp Date 2018-04-30
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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