CABG Surgical Kit Recall Due to Improper Shipping Box Packing
ROi CPS LLC is recalling 85 Regard brand CABG Packs due to incorrect packing into shipping boxes. One North Carolina healthcare facility received the affected kits.
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 2/5 (Moderate).
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 medical device recall with no reported illnesses or injuries. The hazard is improper packing of surgical kits with limited distribution (85 units to one facility), representing a precautionary recall based on a packaging or handling issue rather than an inherent product defect.
Plain-English summary
ROi CPS LLC is recalling Regard brand CABG Pack A and B kits. The recall affects 85 kits (Lot 91156) shipped to one healthcare facility in North Carolina. These sterile surgical kits are used in coronary artery bypass procedures.
The kits were packed incorrectly into shipping boxes at the point of distribution.
Healthcare facilities that received affected kits should contact ROi CPS LLC for replacement or instructions.
The recalled product
- Product
- Regard brand CABG Pack A and B - Spartanburg
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 85
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 (2)
- Item Number: 800208017
- Lot 91156 UDI: (01)10194717112495(17)230101(10)91156
Distribution
Distributed in 1 state:
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