Resource Optimization & Innovation LLC Recalls Pediatric Surgical Kits
Resource Optimization & Innovation LLC is recalling 136 sterile pediatric 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 medical device where a defect (splits/holes in the glove) compromises sterility, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 136 sterile pediatric surgical kits (Item Number 800554001, Lot 23741). The kits are custom procedure trays containing surgical instruments and accessories intended for use during surgical procedures.
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 kits.
The affected kits were distributed to Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, MO.
The recalled product
- Product
- regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - 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 su
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 136
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 number 23741.
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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