FDA Recalls 64 Sterile Peripheral Vascular Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 64 sterile surgical kits because equipment gloves 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. Per the rubric, an FDA Class II recall involving a medical device where sterility is compromised (posing a risk of serious injury or infection) falls under the 'Severe' category, especially given the potential for significant injury from non-sterile surgical instruments.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 64 sterile peripheral vascular surgical kits (Item Number 800615, CV0741). The recall was initiated because the kits contain an equipment glove component that may have splits or holes, which could compromise the sterility of the product.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The specific lot numbers involved in this recall are 18390, 18746, 19702, and 20713.
Healthcare facilities should stop using these kits immediately and contact the recalling firm for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - 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
- 64
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 (4)
- Lot numbers 18390
- 18746
- 19702
- and 20713.
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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