CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report

Respirator Crash Cart Kit recalled by ROi CPS

ROi CPS is recalling Respirator Crash Cart Kit, distributed in Louisiana, Missouri. The recall was initiated on 19 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem #: 830066; Lot #: 77127, 74813 and 63168 Expiration date per lot: Lot: 77127, Exp date: 1/31/2021 Lot: 74813, Exp date: 8/30/2021 Lot: 63168, Exp date: 1/30/2021

Quantity recalled200 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-2466-2020
FDA event ID: 85736
Recalling firm: ROi CPS, Republic, MO
Classification: Class II
Status: Terminated
Recall initiated: 19 May 2020
FDA classified: 26 Jun 2020
Reported: 8 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Masks, Gloves & PPE

Timeline

19 May 2020	Recall initiated by company
26 Jun 2020	Classified by FDA	+38 days
8 Jul 2020	Published in enforcement report	+12 days

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

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.

Product as listed by the FDA

Respirator Crash Cart Kit

Where it was distributed

Domestic distribution only to: MO and LA.

Louisiana Missouri

Questions about this recall

Is Respirator Crash Cart Kit recalled?

Yes. ROi CPS recalled Respirator Crash Cart Kit on 19 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2466-2020.

Why was it recalled?

Which lots are affected?

Item #: 830066; Lot #: 77127, 74813 and 63168 Expiration date per lot: Lot: 77127, Exp date: 1/31/2021 Lot: 74813, Exp date: 8/30/2021 Lot: 63168, Exp date: 1/30/2021

Where was it sold?

Domestic distribution only to: MO and LA.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

More recalls from ROi CPS

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