Surgical Convenience Kits Recalled Due to Included 3M Surgical Drapes
ROi CPS LLC is recalling 54 regard LATERAL SHOULDER surgical convenience kits containing 3M surgical drapes that were subsequently recalled by the manufacturer. Affected kits were distributed to facilities 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: FDA Class II recall for a surgical medical device with no reported illnesses or injuries. Although the specific hazard is not detailed in the source, the regulatory classification indicates a serious but improbable adverse health consequence is possible, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ROi CPS LLC is recalling 54 regard LATERAL SHOULDER, OR01044C surgical convenience kits (Item Number 880435003) because they contain 3M surgical drapes that were subject to recall. The affected kits have UDI/DI 10194717105763 and include two lot numbers: Lot 91403 (expiration 2/4/2024) and Lot 92161 (expiration 4/12/2024).
The recall was initiated because the 3M surgical drapes included in these kits were subsequently recalled. The source documentation does not specify the particular hazard associated with the recalled drapes.
The surgical convenience kits were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
The recalled product
- Product
- regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 54
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 10194717105763
- Lot Numbers: 91403
- exp 2/4/2024
- 92161
- exp 4/12/2024
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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