FDA device enforcement
Regard brand CABG Pack A and B - Spartanburg
Kits were packed into shipping boxes incorrectly.
Class IIReported terminated
Distribution: Recall impacted one domestic consignee in NC
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ROi CPS LLC recall records
13 reported ongoing
68 records in this archive. Latest source date Dec 26, 2024.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Records and reported status
Official source for Regard brand CABG Pack A and B - Spartanburg
FDA device enforcement
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging...
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Class IIReported terminated
Distribution: US Nationwide distribution in the state of Missouri.
FDA device enforcement
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packag...
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Class IIReported terminated
Distribution: US Nationwide distribution in the state of Missouri.
FDA device enforcement
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Class IIReported terminated
Distribution: US Nationwide distribution in the state of Missouri.
FDA device enforcement
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Recalled devices were packaged in convenience kits.
Class IIIReported terminated
Distribution: US Nationwide distribution in the state of Missouri.
FDA device enforcement
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Products are mislabeled with the incorrect product identification on individual kit labeling.
Class IIReported terminated
Distribution: Missouri
FDA device enforcement
Regard, T AND A - Rogers, sterilized convenience kits
Kits lacks rubber latex warning label.
Class IIReported terminated
Distribution: US Nationwide distribution in the state of MO.
FDA device enforcement
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
The kit contains a non-sterile needle.
Class IIReported terminated
Distribution: Distribution was made to Missouri. There was no foreign/military/government distribution.
Reasons in these listed records
- Kits were packed into shipping boxes incorrectly.
- A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
- Recalled devices were packaged in convenience kits.
- Products are mislabeled with the incorrect product identification on individual kit labeling.
These examples come from this result page and are not a ranking of every recall reason.
Checking ROi CPS LLC
Is there a recall on roi cps llc right now?
This archive contains 68 records, including 13 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product?
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included?
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record?
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.