Resource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 36 vaginal hysterectomy surgical kits because a glove component may have splits or holes that compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a sterile medical device where compromised sterility poses a risk of significant injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 36 units of Item Number 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kits. The recall affects kits with lot numbers 17695 and 188144. These custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
The recall was initiated because the kits contain an equipment glove component which may contain splits or holes. These defects may compromise the sterility of the surgical kit. The agency has classified this recall as Class II.
Distribution was made to facilities in Louisiana, Mississippi, and Texas. Healthcare providers and patients should contact Resource Optimization & Innovation LLC for further information regarding the recall and potential replacement or refund.
The recalled product
- Product
- regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 36
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)
- Lot numbers 17695 and 188144.
Distribution
Part of a larger recall action
This product is one of 77 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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