FDA Recalls Pediatric Surgical Kits Due to Potential Sterility Compromise
Resource Optimization & Innovation LLC is recalling 746 sterile pediatric surgical kits because equipment glove components may have splits or holes that compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 746 sterile pediatric surgical kits (Item Number 800554, GS0643) due to a potential sterility issue. The recall involves 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, potentially compromising the sterility of the device. The affected lot numbers are 17909, 19130, and 20209.
Distribution of the affected kits was made to Louisiana, Mississippi, and Texas. Healthcare facilities and consumers should stop using these kits and contact the manufacturer for further instructions.
The recalled product
- Product
- regard Item Number: 800554, Sterile, GS0643 - 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…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 746
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 17909
- 19130
- and 20209.
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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