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.
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 3/5 (High).
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
Related recalls
Same manufacturer · ROi CPS LLC
See all →- SevereNewborn Resuscitator Kit Recalled for Inline Spring Defect
FDA (Devices) · 2025-02-12
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighRegard Kit Decanters Recalled for Defective Sterile Packaging
FDA (Devices) · 2024-08-28
- CriticalSurgical Convenience Kit Recalled Due to Defective Component
FDA (Devices) · 2024-01-24
- SevereRegard Dressing Change Kit Recalled Due to Defective Irrigation Solution
FDA (Devices) · 2024-01-10
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
Similar recalls
- HighROi CPS Recalls Custom Procedure Kits Containing Recalled BD Syringes
FDA (Devices) · 2020-06-17
- ModerateRegard Custom Procedure Kits with BD Luer Lok Access Devices Recalled
FDA (Devices) · 2022-04-06
- HighRegard Shoulder surgical kits recalled due to defective included drapes
FDA (Devices) · 2022-11-30
- HighFDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- HighResource Optimization Recalls 28 Custom Cardiovascular Surgical Kits
FDA (Devices) · 2015-11-04
- HighResource Optimization Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04