Resource Optimization & Innovation Recalls Sterile C Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 222 sterile C Section 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 kit) where sterility is compromised, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 222 sterile C Section surgical kits (Item Number 800514, LD0592). The kits contain surgical instruments and accessories intended for use during a surgical procedure. The recall is due to a defect where the equipment glove component may contain splits or holes, which compromises the sterility of the kit.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The specific lot numbers involved in this recall are 16235, 19073, 19511, 20078, 20239, 20868, and 21849.
Healthcare facilities and consumers should stop using these kits immediately and contact Resource Optimization & Innovation LLC for instructions on how to return the product.
The recalled product
- Product
- regard Item Number: 800514, Sterile, LD0592 - C Section Pack - 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 surgic
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 222
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 (7)
- Lot numbers 16235
- 19073
- 19511
- 20078
- 20239
- 20868
- and 21849.
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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