Z-0837-2022Class III

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

Name: Z-0837-2022 Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Creator: ROi CPS LLC
Published: 2022-02-24
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2022-02-24 / Terminated / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of Regard Custom Procedure Kits containing BD Luer Lok Access Devices on 2022-02-24. FDA classified it as Class III and gives the reason as "Recalled devices were packaged in convenience kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0837-2022
Classification: Class III
Status: Terminated
Initiated: 2022-02-24
Posted: 2022-03-30
Terminated: 2022-04-25
Recalling firm: ROi CPS LLC
Product: Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Product code: LRS I.V. Start Kit
Reason for recall: Recalled devices were packaged in convenience kits.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: A customer letter dated February 24, 2022 was issued to the impacted consignee. The letter instructs the consignee to perform a microscopy to confirm an elevated RBC count in a urine sample as the impacted component may shed contaminant particles that are identified as RBCs when used in conjunction with the Sysmex UF-1000i or UX-2000 analyzers. A reply form should be completed and returned to ROi confirming receipt and understanding of the notification. End users should retain a copy of the BD notice and post near the analyzer as a visual reminder of the potential issue with the BD product.
Quantity in commerce: 1750 kits
Distribution: US Nationwide distribution in the state of Missouri.
Product codes and lots: IV START LABOR BIRTH convenience kits: 1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002, Lots 91226, 90641, and 90446 (exp. MAY/12/2022)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0837-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0837-2022	Class III	Terminated	Voluntary: Firm initiated	2022-04-06	2022-03-30

Product code LRS

K991088Class IIVacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood ColleBecton Dickinson Vacutainer Systems / cleared 1999-05-28

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)