FDA Recalls 24 Sterile Breast Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 24 sterile breast surgical kits because the equipment glove component may contain 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, FDA Class II recalls with potential for significant injury (such as compromised sterility leading to infection) are rated as Severe (4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 24 sterile breast surgical kits manufactured by Resource Optimization & Innovation LLC. The affected product is identified as Item Number 880321, GS0752 - Breast Pk, which is a custom procedure tray containing surgical instruments and accessories intended for use during a surgical procedure. The recall is limited to Lot numbers 20659 and 23786.
The recall was initiated because the kits contain an equipment glove component that may contain splits or holes. These defects may compromise the sterility of the surgical kit, posing a risk of infection or other adverse health consequences to patients during use. The agency classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
Distribution of the affected kits was made to facilities in Louisiana (LA), Mississippi (MS), and Texas (TX). Healthcare facilities and consumers who have these specific kits should stop using them immediately and contact Resource Optimization & Innovation LLC or the FDA for instructions on how to return the product.
The recalled product
- Product
- regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 24
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 20659 and 23786.
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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