Surgical Convenience Kits Recalled Due to Unsafe 3M Surgical Drapes
ROi CPS LLC is recalling 18 regard KYPHOPLASTY surgical convenience kits that contained recalled 3M surgical drapes. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The recall is precautionary in nature, initiated because the kits contained surgical drapes that were subject to a separate product recall.
Plain-English summary
ROi CPS LLC is recalling the regard KYPHOPLASTY surgical convenience kit, model OR01101 (Item Number 880469), intended for orthopedic surgical procedures. The affected product includes 18 kits with UDI/DI 10194717109723, Lot Number 91417, expiration date 2/2/2024.
These surgical convenience kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida. The recall was initiated because the kits contained 3M surgical drapes that were themselves subject to a separate product recall.
Facilities that received the affected kits should verify inventory against the lot number and expiration date listed. Further information regarding this recall is available through the FDA Medical Device Recall database.
The recalled product
- Product
- regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kit
- Hazard
- Affected units
- 18
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)
- UDI/DI 10194717109723
- Lot Numbers: 91417
- exp 2/2/2024
Distribution
Part of a larger recall action
This product is one of 40 recalled by ROi CPS 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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