CLASS III Device recall · Reported 6 Apr 2022 · FDA Enforcement Report

Regard Custom Procedure Kits containing BD Luer Lok Access Devices recalled

ROi CPS is recalling Regard Custom Procedure Kits containing BD Luer Lok Access Devices, distributed nationwide in the US. The recall was initiated on 24 Feb 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesIV 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)

Quantity recalled1750 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0837-2022
FDA event ID: 89710
Recalling firm: ROi CPS, Republic, MO
Classification: Class III
Status: Terminated
Recall initiated: 24 Feb 2022
FDA classified: 30 Mar 2022
Reported: 6 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

24 Feb 2022	Recall initiated by company
30 Mar 2022	Classified by FDA	+34 days
6 Apr 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Recalled devices were packaged in convenience kits.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

Where it was distributed

US Nationwide distribution in the state of Missouri.

Nationwide Missouri

Questions about this recall

Is Regard Custom Procedure Kits containing BD Luer Lok Access Devices recalled?

Yes. ROi CPS recalled Regard Custom Procedure Kits containing BD Luer Lok Access Devices on 24 Feb 2022. The recall is Class III and its status is Terminated. Recall number Z-0837-2022.

Why was it recalled?

Recalled devices were packaged in convenience kits.

Which lots are affected?

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)

Where was it sold?

US Nationwide distribution in the state of Missouri.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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