Resource Optimization & Innovation Recalls Sterile Abdominal Surgical Kits
Resource Optimization & Innovation LLC is recalling 712 sterile abdominal surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
What this means for you
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 kits) where sterility is compromised, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 712 sterile abdominal surgical kits, Item Number 800546, GS0635. These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures. The recall is due to the equipment glove component potentially containing splits or holes that compromise the sterility of the kits.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The specific lot numbers involved in this recall are 17698, 19354, 19508, 20805, 21595, and 22841. The responsible firm on the label is ROi, LLC, located in St. Louis, Missouri.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected kits immediately. Users should contact Resource Optimization & Innovation LLC for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- regard Item Number: 800546, Sterile, GS0635 - Abdominal - 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 pr
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 712
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 (6)
- Lot numbers 17698
- 19354
- 19508
- 20805
- 21595
- and 22841.
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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