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.
What this means for you
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
- recalled-component
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
Distributed in 4 states:
- FL
- LA
- MO
- NC
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