Z-2465-2020Class II

Isolation Droplet Bundle Kit

Name: Z-2465-2020 Isolation Droplet Bundle Kit
Creator: ROi CPS LLC
Published: 2020-05-19
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2020-05-19 / Terminated / root cause: labeling and UDI

FDA source

ROi CPS LLC began a recall of Isolation Droplet Bundle Kit on 2020-05-19. FDA classified it as Class II and gives the reason as "Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2465-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-19
Posted: 2020-06-26
Terminated: 2020-09-01
Recalling firm: ROi CPS LLC
Product: Isolation Droplet Bundle Kit
Product code: OEA Non-Surgical Gown
Reason for recall: Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On May 19, 2020 Roi CPS LLC notified its customers to review their inventory to determine if the custom procedure kit item and lot identified were on their inventory. If identified, please quarantine and notify Roi of the quantity on hand completing the reply form provided to them via email and to forward this notification to all potential user of the recall.
Quantity in commerce: 24 kits
Distribution: Domestic distribution only to: MO and LA.
Product codes and lots: Item: 830006013, Lot #: 78253M

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2465-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2465-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2466-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26

Product code OEA

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)