Recall of Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation Llc is recalling 30 sterile custom procedure trays 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 High severity criteria.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 30 kits of Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU. The affected product is a custom procedure tray containing a light glove component.
The recall was initiated because the light glove can split during application to a light handle. This failure can break the sterile field, which is a critical safety requirement for sterile medical procedures.
The affected units were distributed in the US to locations in LA and TX. The specific code information for the recalled items is 032677F with an expiration date of 2017-12-30. Users of these trays should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 30
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)
- 032677F Exp Date 2017-12-30
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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