Resource Optimization & Innovation Recalls Sterile Hip Shoulder Surgical Kits
Resource Optimization & Innovation LLC is recalling 92 sterile hip shoulder surgical kits because equipment glove components may have 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 (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 92 sterile hip shoulder surgical kits (Item Number 800527, OR0611). The kits contain surgical instruments and accessories intended for use during surgical procedures. The recall is due to equipment glove components that may contain splits or holes, which could compromise the sterility of the kits.
The affected lots are 16407, 18358, and 18879. Distribution was made to Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Healthcare facilities and consumers should stop using the affected kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder 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 surgi
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 92
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 16407
- 18358
- and 18879.
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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