FDA Recalls Pacemaker Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 40 pacemaker surgical kits because equipment gloves 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect compromises sterility in surgical kits, which poses a significant risk of infection or injury during surgery.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 40 pacemaker surgical kits manufactured by Resource Optimization & Innovation LLC. The recall is due to a defect in the equipment glove component, which may contain splits or holes that compromise the sterility of the kits.
The affected product is a custom procedure tray containing surgical instruments and accessories intended for use during a surgical procedure. The specific item number is 880328, and the kits are sterile. The recall covers lot numbers 20408, 21922, and 24030. Distribution was made to facilities in Louisiana, Mississippi, and Texas.
Healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or replacement. Patients who have already had procedures using these kits should consult their healthcare provider if they have concerns about potential sterility issues.
The recalled product
- Product
- regard Item Number: 880328, Sterile, HT0759 - Pacemaker 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…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 40
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 20408
- 21922
- and 24030.
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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