Regard SPINE Surgical Kits Recalled for Containing Unsafe Drapes
ROi CPS LLC is recalling 302 Regard SPINE surgical convenience kits containing 3M surgical drapes that were subject to an FDA recall. Affected kits were distributed 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: This FDA Class II recall involves surgical drapes used in sterile surgical procedures. No illnesses or injuries have been reported, but surgical drapes are high-risk medical devices where compromised equipment could result in patient harm during operation.
Plain-English summary
ROi CPS LLC is recalling 302 Regard SPINE (OR01100A, Item Number 880468001) surgical convenience kits. The kits contained 3M surgical drapes that were subject to an FDA recall.
The 3M surgical drapes included in these kits were themselves recalled by the FDA. As a result, all surgical convenience kits containing these recalled drapes are also being recalled.
The affected kits were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. The specific lot numbers involved are 91240 (expiration 8/3/2023) and 92740 (expiration 2/14/2024).
Healthcare facilities that received these kits should stop using them immediately and contact ROi CPS LLC for information regarding proper handling, disposal, and replacement of the recalled kits.
The recalled product
- Product
- regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 302
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 10194717113713
- Lot Numbers: 91240
- exp 8/3/2023
- 92740
- exp 2/14/2024
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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