Hip Arthroscopy Surgical Convenience Kits Recalled Containing Recalled Drapes
ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.
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 or injuries. The recall is precautionary, initiated because the kits contain surgical drapes that were themselves subject to recall.
Plain-English summary
ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits (Item Number 880462002, UDI/DI 10194717109426). This recall was initiated because the kits contain 3M surgical drapes which were subsequently recalled.
Twenty-four surgical convenience kits were distributed to locations in Louisiana, Missouri, North Carolina, and Florida. The affected lot numbers are 90993 (expiration date 10/11/2023) and 91722 (expiration date 1/12/2024).
Persons with access to these kits should be aware that they contain surgical drape components that were subject to recall and should not be used for their intended purpose.
The recalled product
- Product
- regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 24
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)
- UDI/DI 10194717109426
- Lot Numbers: 90993
- exp 10/11/2023
- 91722
- exp 1/12/2024
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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