Surgical Convenience Kits Recalled Due to Included 3M Drape Components
Orthopaedic surgical convenience kits distributed in four states contained 3M surgical drapes that were subsequently recalled. ROi CPS LLC is recalling 38 affected kits.
What this means for you
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: FDA Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The recall is precautionary in nature due to inclusion of previously recalled 3M drape components.
Plain-English summary
ROi CPS LLC is recalling regard HAND PACK surgical convenience kits (OR00594K, Item Number 800243011) distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subsequently recalled.
Thirty-eight surgical convenience kits with Lot Number 92200 and an expiration date of April 14, 2024 are affected. These kits can be identified by UDI/DI 10194717110682. Healthcare facilities and individuals who have received these kits should contact ROi CPS LLC.
The recalled product
- Product
- regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
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 10194717110682
- Lot Numbers: 92200
- exp 4/14/2024
Distribution
Distributed in 4 states:
- FL
- LA
- MO
- NC
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