FDA Recalls 726 Sterile Laparoscopic Cholecystectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 726 sterile surgical kits because a glove component 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of compromised sterility in surgical instruments.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 726 sterile surgical kits intended for laparoscopic cholecystectomy procedures. The kits are manufactured by Resource Optimization & Innovation LLC (ROi, LLC) of St. Louis, Missouri, and are identified by Item Number 800551 and model GS0640. The affected lots are 16584, 18145, 18553, and 18359.
The recall was initiated because the kits contain an equipment glove component that may have splits or holes. These defects can compromise the sterility of the surgical instruments and accessories contained within the tray. The kits were distributed to facilities in Louisiana, Mississippi, and Texas.
Healthcare facilities should stop using the affected kits immediately and contact the manufacturer for instructions on return or replacement. Patients who have already undergone surgery using these kits should contact their healthcare provider if they have concerns about potential infection or other complications.
The recalled product
- Product
- regard Item Number: 800551, Sterile, GS0640 - Lap Chole - 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…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 726
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 16584
- 18145
- 18553
- and 18359
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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