Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,400 sterile C-section 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 medical device where a defect (splits/holes in gloves) compromises sterility, creating a risk of infection or harm during surgery. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 1,400 sterile C-section surgical kits (Item Number 800408001, LD0477A). The recall was initiated because the kits contain an equipment glove component which may contain splits or holes, potentially compromising the sterility of the product.
The affected kits are custom procedure trays containing surgical instruments and accessories intended for use during a surgical procedure. The distribution was made to Louisiana, Mississippi, and Texas. The specific lot numbers involved are 18235, 19608, 20169, 20976, 21911, and 23947.
Healthcare facilities and consumers should stop using these kits and contact the recalling firm for further instructions. The responsible firm on the label is ROi, LLC, located in St. Louis, MO.
The recalled product
- Product
- regard Item Number: 800408001, Sterile, LD0477A - C-Section 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 surg
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,400
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 18235
- 19608
- 20169
- 20976
- 21911
- and 23947.
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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