ROi CPS Recalls Regard Custom Cardiovascular Procedure Kits
ROi CPS LLC is recalling 16 Regard custom cardiovascular procedure kits because drape slits may breach the sterile barrier.
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: The recall is classified as FDA Class II, and the hazard involves a potential breach of the sterile barrier in a medical device, which poses a risk of harm even though no injuries are reported.
Plain-English summary
ROi CPS LLC is recalling 16 units of Regard custom cardiovascular procedure kits, Item Number 830067009. The recall was initiated after the company received an urgent medical device recall notice from a vendor.
The recall is due to a defect in the drapes contained within the procedure trays. These drapes may have slits that could lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment. The affected products have lot number 75818I and an expiration date of 05/18/2021.
The products were distributed nationwide in the United States, specifically within the state of Missouri. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Regard, Item Number 830067009, custom cardiovascular procedure kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 16
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)
- Lot number: 75818I
- Expiration Date: 05/18/2021
Distribution
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