Surgical Convenience Kits Recalled for Containing Recalled 3M Surgical Drapes
ROi CPS LLC is recalling 170 surgical convenience kits containing 3M surgical drapes that were previously recalled. 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Surgical drapes are critical medical devices used in sterile environments. Although the specific hazard is not disclosed in the source, the FDA Class II classification and the nature of the product as surgical equipment indicates risk-of-harm, and no illnesses or injuries have been reported.
Plain-English summary
ROi CPS LLC is recalling 170 surgical convenience kits (item number 800203006, UDI/DI 10194717107392) distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida. The recall was initiated because the kits contain 3M surgical drapes that were subsequently recalled.
The affected kits include lot numbers 91107 (expiration 1/8/2024) and 91879 (expiration 3/18/2024). This is a secondary recall—the kits themselves are being recalled because they contain a component that was already identified as problematic.
Facilities that received these kits are advised to contact ROi CPS LLC or the FDA for instructions on returning, replacing, or disposing of the affected inventory.
The recalled product
- Product
- regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 170
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 10194717107392
- Lot Numbers: 91107
- exp 1/8/2024
- 91879
- exp 3/18/2024
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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