REGARD Ultrasound Trays Recalled for Out-of-Specification Swabstick Component
ROi CPS LLC has recalled REGARD Ultrasound Trays because they contain out-of-specification Povidone-Iodine swabstick components. The 240 affected trays were distributed in Florida, Louisiana, and Missouri.
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 is a Class II FDA recall, which indicates the potential for serious adverse health consequences from the out-of-specification medical device component. Although no illnesses or injuries have been reported, the safety implications of a defective medical device component justify a High severity rating.
Plain-English summary
ROi CPS LLC is recalling REGARD Ultrasound Trays. The reason for the recall is that these trays contain Povidone-Iodine swabstick components manufactured by PDI, Inc. that do not meet product specifications. The recalled products include 240 trays with lot numbers 87414C, 87035C, 86918C, 88755C, and 85539C.
The affected REGARD Ultrasound Trays were distributed nationwide in Florida, Louisiana, and Missouri. This is an FDA Class II recall initiated due to the out-of-specification nature of the swabstick components.
The recalled product
- Product
- REGARD Ultrasound Tray
- Manufacturer
- ROi CPS LLC
- Hazard
- out-of-specification
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 (4)
- Lots numbers: 87414C
- 87035C
- 86918C
- 88755C and 85539C
Distribution
Distributed nationwide across the United States.
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