Surgical convenience kits recalled for containing recalled 3M drapes
Orthopedic surgical convenience kits distributed in four states were recalled because they contain 3M surgical drapes that were subject to a separate recall.
What this means for you
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, injuries, or deaths. The recall is a consequence of included 3M surgical drapes being subject to a separate recall. With no specific hazard articulated in this source text and no reported harm, this qualifies as a moderate precautionary recall.
Plain-English summary
ROi CPS LLC is recalling the regard FOOT PACK (OR00123Y) orthopedic surgery convenience kit due to the inclusion of 3M surgical drapes that were subsequently recalled. A total of 204 kits were affected.
The recalled kits have Lot Number 91622 with an expiration date of February 22, 2024, and are identified by UDI/DI 10194717103288. These kits were distributed to locations in Louisiana, Missouri, North Carolina, and Florida.
The primary concern is that these convenience kits were distributed containing surgical drapes from 3M that are subject to a separate recall. The FDA is issuing this recall to notify recipients of these convenience kits regarding the presence of the recalled component.
The recalled product
- Product
- regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Supply
- Hazard
- Affected units
- 204
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 (3)
- UDI/DI 10194717103288
- Lot Number 91622
- exp 2/22/2024
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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