Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Risk
Resource Optimization & Innovation LLC is recalling 7,904 sterile surgical kits because the equipment 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 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 the defect compromises sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 7,904 sterile surgical kits, identified as Item Number 800401, GS0470 - Lap Pk. These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures. The recall involves specific lot numbers: 14885, 15130, 15341, 16473, 16517, 17011, 17763, 18081, 18483, 18740, 19106, 19242, 19977, 20399, 20540, 21255, 21599, and 22478.
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 kits. The affected products were distributed to facilities in Louisiana, Mississippi, and Texas.
Healthcare facilities and consumers should stop using these specific surgical kits immediately. Users should check their inventory for the item number and lot numbers listed above. If the product is found, it should be quarantined and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- regard Item Number: 800401, Sterile, GS0470 - Lap 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 surgical…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 7,904
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 (18)
- Lot numbers 14885
- 15130
- 15341
- 16473
- 16517
- 17011
- 17763
- 18081
- 18483
- 18740
- 19106
- 19242
- 19977
- 20399
- 20540
- 21255
- 21599
- and 22478.
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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