Recall of Regard Major Vaginal PK Sterile Procedure Trays
Resource Optimization & Innovation LLC is recalling 28 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 risk-of-harm product (breaking the sterile field) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 28 kits of Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn. The recall involves custom procedure trays that contain a light glove component. The affected units have the code 026166A and an expiration date of 2017-07-06.
The recall was initiated because the light glove component can split during application to a light handle. This splitting action can break the sterile field, which is a critical safety requirement for sterile medical procedures.
The product was distributed in the United States to locations in Louisiana and Texas. Healthcare facilities and consumers who have these specific trays should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 28
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)
- 026166A Exp Date 2017-07-06
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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