Resource Optimization & Innovation Recalls 164 Arthroscopy Surgical Kits
Resource Optimization & Innovation LLC is recalling 164 arthroscopy surgical kits because equipment glove components 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 (compromised sterility in surgical kits) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 164 arthroscopy surgical kits (Item Number: 800422001, OR0491A). The kits contain surgical instruments and accessories intended for use during surgical procedures. The recall involves lot numbers 18921 and 19204.
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. The distribution of these kits was made to Louisiana, Mississippi, and Texas.
Healthcare facilities and consumers should stop using the affected kits and contact the recalling firm for instructions on return or replacement. The responsible firm on the label is ROi, LLC, located in St. Louis, MO.
The recalled product
- Product
- regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy 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 sur
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 164
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 18921 and 19204.
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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