Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves
Resource Optimization & Innovation LLC is recalling 450 Regard custom procedure trays because the included light gloves 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 is classified as FDA Class II and involves a risk-of-harm product (breaking the sterile field) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 450 kits of Regard custom procedure trays (Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn). The recall was initiated because a component included in the trays, a light glove, can split during application to a light handle. This splitting action breaks the sterile field, which is a critical safety requirement for medical procedures.
The affected products were distributed in the United States to locations in California (LA) and Texas (TX). The specific lot codes and expiration dates for the recalled items are 030228A (Exp Date 2017-12-23), 031467A (Exp Date 2018-02-09), and 032767A (Exp Date 2018-04-07).
Healthcare facilities and consumers who have these specific trays should stop using them immediately. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 450
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 (3)
- 030228A Exp Date 2017-12-23
- 031467A Exp Date 2018-02-09
- 032767A Exp Date 2018-04-07
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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