Resource Optimization & Innovation Recalls 516 Sterile Lap Chole Surgical Kits
Resource Optimization & Innovation LLC is recalling 516 sterile surgical kits because equipment glove components 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 medical device where a defect (splits/holes in gloves) compromises sterility, creating a risk of harm (infection) during surgical procedures. As no specific injuries or illnesses are reported in the source text, this falls under the 'risk-of-harm products where injury has not yet been reported' criterion for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 516 sterile surgical kits, specifically the GS0612 Lap Chole Pk (Item Number 800528). These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures. The recall involves lot numbers 16835, 18906, and 19507.
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, posing a risk of infection or other complications during use.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. 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: 800528, Sterile, GS0612 - 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
- 516
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 (3)
- Lot numbers 16835
- 18906
- and 19507.
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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