FDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because a glove component 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 is classified as FDA Class II and involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 57 sterile pediatric heart surgical kits (Item Number 800565001, CV0654A) due to a potential sterility issue. The recall is classified as Class II by the FDA.
The kits contain an equipment glove component that may have splits or holes, which could compromise the sterility of the surgical instruments and accessories. The affected lots are 19532, 23789, 24399, and 24478.
Distribution was made to Louisiana, Mississippi, and Texas. Healthcare facilities and consumers should stop using these kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - 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
- Hazard
- Affected units
- 57
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 (4)
- Lot numbers 19532
- 23789
- 24399
- and 24478.
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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