FDA Recalls 924 Sterile Lap Chole Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 924 sterile surgical kits because equipment glove components 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 3/5 (High).
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 involves a risk-of-harm product (sterile surgical kit) where sterility is compromised, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 924 sterile surgical kits, specifically the GS0612A Lap Chole Pk (Item Number 800528001). The recall is being conducted because the kits contain an equipment glove component which may contain splits or holes, a defect that compromises the sterility of the product.
The affected lots are 20187, 20502, 22697, and 24264. Distribution of these kits was made to facilities in Louisiana, Mississippi, and Texas. The kits are custom procedure trays containing surgical instruments and accessories intended for use during a surgical procedure.
Healthcare facilities and consumers who have these specific kits should stop using them immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - 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
- 924
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 20187
- 20502
- 22697
- and 24264
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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