FDA Recalls Sterile Vaginal Procedure Kits Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 56 sterile major vaginal procedure kits because a light glove component may split during use, 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. The hazard involves breaking the sterile field, which poses a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 56 kits of Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn. The recall is due to a defect in a light glove component included in the custom procedure trays. The glove can split during application to a light handle, which breaks the sterile field.
The affected products were distributed in the United States to locations in California (LA) and Texas (TX). The specific lot codes associated with this recall are 037420C with an expiration date of 2018-08-12 and 039995C with an expiration date of 2018-12-02.
Healthcare facilities and consumers should stop using these specific kits immediately. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 56
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 (2)
- 037420C Exp Date 2018-08-12
- 039995C Exp Date 2018-12-02
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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