FDA Recalls VP Shunt Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 200 VP Shunt surgical kits because equipment gloves 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 the hazard involves a risk of harm (compromised sterility) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 200 VP Shunt surgical kits manufactured by Resource Optimization & Innovation LLC. The kits, identified by Item Number 800566 and Sterile code NU0655, are custom procedure trays containing surgical instruments and accessories intended for use during surgical procedures.
The recall is being conducted because the kits contain an equipment glove component that may have splits or holes, which could compromise the sterility of the surgical instruments. The affected lots are 17911, 19052, 19414, 20220, and 24071.
Distribution of these kits was made to facilities in Louisiana, Mississippi, and Texas. The FDA has not reported any illnesses or injuries associated with this recall. Healthcare facilities should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- regard Item Number: 800566, Sterile, NU0655 - VP Shunt - 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 surgical pro
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 200
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 (5)
- Lot numbers 17911
- 19052
- 19414
- 20220
- and 24071.
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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