Z-2685-2024Class II

Regard Kit containing the Microtek decanter

Name: Z-2685-2024 Regard Kit containing the Microtek decanter
Creator: ROi CPS LLC
Published: 2024-06-17
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2024-06-17 / Open, Classified / root cause: packaging

FDA source

ROi CPS LLC began a recall of Regard Kit containing the Microtek decanter on 2024-06-17. FDA classified it as Class II and gives the reason as "Decanters may have pin holes and tears in sterile packaging that cannot be identified visually". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2685-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-17
Posted: 2024-08-16
Recalling firm: ROi CPS LLC
Product: Regard Kit containing the Microtek decanter
Product code: KPE Container, I.V.
Reason for recall: Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Root cause tag: packaging
FDA root cause: Pending
Action: The distributor was notified of the recall via letter emailed on 06/17/2024. The distributor was instructed to review their inventory to determine if the item listed in the letter is in the inventory; complete and return a response form, notify any customers to whom the product was distributed, end users should immediately quarantine any affected kits at their facility and discontinue use, and report any adverse health consequences experienced with the product to FDA.
Quantity in commerce: 78 Kits
Distribution: US Nationwide distribution in the state of MO.
Product codes and lots: Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2685-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2685-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16

Product code KPE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)