Recall of Regard Sterile Major Basin Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 1,548 sterile 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 medical device where a defect can break the sterile field, creating a risk of harm (infection) that has not yet been reported as an injury or illness, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 1,548 kits of Regard, Item Number 880326001, Sterile, GS0757A - Major Basin - OSU. These are custom procedure trays distributed to locations in Louisiana and Texas. The affected lots have expiration dates ranging from July 16, 2017, to June 17, 2018.
The recall is being conducted 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 trays should stop using them and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 1,548
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 (5)
- 026446A Exp Date 2017-07-16
- 030247A Exp Date 2017-12-28
- 032384A Exp Date 2018-03-22
- 033038A Exp Date 2018-04-20
- 034310A Exp Date 2018-06-17
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.
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